Clinical trials are complicated and are becoming more so, driven by large global studies, increasing demands from regulatory agencies, and the introduction of new technologies. A number of advances in drug development in the pharmaceutical industry are specifically linked to the data services component, including those in the areas of data management, biostatistics, statistical programming, and medical writing. 

Some of the recent industry trends that impact these businesses include electronic data capture (EDC), eDiaries, and adaptive trial design. The Clinical Data Interchange Standards Consortium (CDISC) and the electronic Common Technical Document (eCTD) are examples of trends in standardization that will benefit industry and the FDA. In turn, they also affect activities within the data services portion of clinical trials. These changes are intended to accelerate the pace at which clinical trials are conducted and data are made available for analysis and reporting.

To meet these challenges and promote the proactive management of the data services aspects of a trial, the addition of a project manager with a data-oriented background is critical. 

Having data- and analysis-oriented individuals direct the data services activities of a clinical trial is not new. Typically, a CRO uses a team model in which a clinical project manager is assigned to lead a full team. The clinical project manager shares responsibility with functional team members, such as the lead data manager or lead statistician. The technical leads are responsible for day-to-day management of the data functions and they report project status to the clinical project manager. 

With this shared responsibility between the clinical project manager and functional team members to secure project delivery, a project challenge is introduced. Each team member brings his or her own expertise, yet neither the clinical project manager nor the functional team member is uniquely skilled to bring both project leadership and the full scope of all data services expertise to the role. 

To address the challenges introduced by the sharing of responsibilities and to achieve both team efficiency and project success, i3 Statprobe, an Ann Arbor, MI-based clinical data services provider, has established a unique role: the data services project manager (DSPM). The drivers behind the concept of a DSPM are two-fold. 

First, the DSPM relieves operations team members from a role in which they have one foot in project management and the other foot in the operational conduct of the project. By removing project management tasks such as timeline adjustments, budget management, meeting facilitation, and communication leadership from operational team members, they are free to apply their skills to their specialized areas of expertise. 

Second, the DSPM augments the study team with a project manager who is specifically trained in data services, allowing the team to benefit from the proactive management of its tasks. 

Much like the conductor of an orchestra, the DSPM directs and coordinates activities across the data services aspects of the study team—such as data management, biostatistics, statistical programming, and medical writing—to achieve desired effects: timeliness of deliverables, cost control, effective resource planning, quality of deliverables, and an exceptional level of customer service. Based on the DSPM's operational knowledge and experience, they are tuned to the detailed process steps that, if not on track, have the potential to cause delays and other project issues. 

DSPMs excel in data service areas of expertise and have the desire and aptitude to conduct and coordinate activities across functions. Individuals who combine operational expertise with strong project management skills bring tremendous value to a trial—particularly when data services make up a large portion of the trial responsibilities. The DSPM role has a much broader reach and a far greater impact on project success and customer satisfaction than the administrative activities of leading meetings, typing up meeting minutes, and updating timelines. 

As an experienced leader, the DSPM is someone whose depth of knowledge across all service areas has prepared him or her to ask the right questions at the right time in order to proactively direct the team and help the customer avoid costly missteps. The DSPM conducts and leads each group and harmonizes their individual efforts, culminating in successful project delivery. 

In the case of stand-alone data services projects, the DSPM is the primary contact with the customer and uses the skills described earlier to assume full responsibility for the overall project timelines, quality of deliverables, resource and budget management, and customer relationship. In the case of a full-service project, the DSPM leads the data services portion of the study, as once again described earlier, and reports status directly to the clinical project manager. 

The paradigm shift from the traditional team model to one that includes a project manager who is uniquely qualified to lead the data services portion of a trial is a key to meeting the challenges of an ever changing industry. And the role and responsibilities of the DSPM dovetail sensibly with the needs created by the increased complexity of today's clinical trials, and increased pressure on the back-end of studies to meet tight timelines with high-quality deliverables. 

With the addition of a DSPM to the management of trials, a sponsor is given greater assurance that the CRO will achieve its operational obligations and exceed their expectations. 

Case study one: Setting the pace on an accelerated data services engagement

 Our client, a drug discovery and development company, requested that we freeze the database early in order to help them meet changing internal timelines. A further complication resulted when four novice lab vendors who worked on the project failed to follow operational guidelines that had been agreed to by all parties. 

 The DSPM's strong leadership and understanding of operational processes gave team members the freedom to focus on their tasks. Our DSPM facilitated communication with the client and between operations so that the data management (DM) lead could focus on cleaning the data. By lifting project management tasks such as timeline adjustments, budget management, meeting facilitation, and communication leadership from team members, the DSPM freed members of the project team to spend time applying their areas of expertise to technical tasks, not project management activities. 

 A quick, clean database critical to client success. The resulting database was not only successfully frozen two weeks ahead of time, it was produced in a very clean manner, with zero queries between lock and freeze—an outcome that proved critical to meeting the client's organizational goals. 

Case study two: A DSPM and FSPM both team up to succeed on a global scale

 A large pharmaceutical company requested that an interim Clinical Study Report (CSR) and analysis be treated as end-of-study deliverables rather than as a snapshot of the data. Meanwhile, a shortened timeline accelerated the end date of the project by approximately four weeks. Our engagement with the client was a global, full-service project in five countries. It involved processing 26,000 CRF pages and issuing and resolving 1700 queries, some of which were received as a bolus in preparation for the interim analysis. This study was one among four running simultaneously for this client. 

 Leveraging their strong relationship, the full-service project manager (FSPM) and the DSPM took a "divide and conquer" approach. The FSPM and the DSPM first divided and prioritized the work based on their time zones and core competencies. The FSPM assumed responsibility for site management, comonitoring, conducting drug safety activities, and developing detailed metrics for monitoring, CRF retrieval, and data clarification form management—all areas that would prove extremely beneficial to data services team members. Meanwhile, the DSPM assumed responsibility for leading the data services team in the rapid movement of data through the system with a level of cleanliness typical for study close. 

Three FSPMs were assigned to cover the four studies running concurrently. Our response was to have one DSPM cover all four studies, which allowed that DSPM to prioritize and coordinate the workload between all studies. This arrangement positioned the DSPM to be fully aware of and respond quickly to the priorities of each of the four studies. 

 A very satisfied client, who has returned for additional services. The CSR was delivered on time without compromising the status of any of the client's other studies. Achieving the necessary goals within the time frame provided by the client required tremendous coordination among all project participants. The arrangement engineered between the FSPM and DSPM exemplifies the concept of the second driver of the model: providing the study team with a project manager who is specifically trained in data services, which allows the team and client to benefit from the proactive management of their tasks. 

Case study three: Filling in the gaps for EDC success

 No detailed timeline was available for this medical device company's project—only the major milestones were known. For an engagement revolving around electronic data capture (EDC) and involving 500 subjects, trying to follow a road map full of holes presented difficulties for the entire data services team. 

 The DSPM's depth of knowledge emerged as the key to coordinating activities. Our DSPM stepped in to provide timeline management as well as leadership on budget management, meeting facilitation, and communications. The DSPM developed a timeline with detailed process steps, predecessors, and linked tasks to coordinate activities across functions. Due to his depth of knowledge across all service areas, the DSPM was able to ask the right questions at the right times to effectively direct the team and successfully keep the customer out of harm's way. 

 The leadership not only met but exceeded client expectations. The level of leadership demonstrated by the DSPM on this project enabled both the internal team and the client a clear view of deliverable dates, all of which were met. Moreover, the clients expressed their appreciation of the expanded understanding our organization brought to the project regarding the detail behind and between each task, which it recognized as absolutely essential to the team's success. 

1. J.A. Quinlan and M. Krams, "Implementing Adaptive Designs: Logistical and Operational Considerations," Drug Information Journal, 40, 437-444 (2006). 

2. S.H. Collins, "EDC and the Changing Role of the Clinical Data Manager," Data Basics, 13 (4) (Winter 2007). 

3. T. Pratt, "Data Management: R.I.P. or Brave New World?" Applied Clinical Trials, 15 (10) 58-64 (2006). 

 is senior director, strategic services, at i3 Statprobe, 300 West Morgan Road, Ann Arbor, Michigan 48108 email: 

Articles

Feature Article

DSPMs offer a new skill set to drive data-heavy clinical trials and meet the needs of an evolving landscape.

The Changing Role of Data Services Project Managers

New legislation on the use of animals in experimentation looms ever larger in Europe, as officials in Brussels squabble over the final draft of a proposal to update the rules in place now for more than 20 years. There are strong pressures from animal protection groups in Europe for stricter regulation. Without doubt, the controls that will be put in place over the coming months—or rather years, given the pace of the European Union's legislative machinery—will be tighter than at present, with provisions on everything from allowable species to record keeping and husbandry. Equally inevitable, any restrictions on the scope for testing in animals will have their impact on first-in-man trials. 

The challenges were discussed at a workshop organized during the summer by the ethics working party of the European Forum for Good Clinical Practice (EFGCP), with the support of the European Commission and the European Federation of Pharmaceutical Industries and Associations. The unusual gathering brought together a broad range of interests—researchers, clinicians, patients, policy makers, regulators, ethicists, and proponents of animal welfare. The focus was how best to reach a decision on when there is enough animal data to justify going into man, while taking account of animal protection needs. The aim was to reflect on possible ethical guidance or principles that can be used in this ethical dilemma by investigators, ethics committees, and competent authorities—in other words, the best balance between reducing animal testing while offering the highest possible safety for trial subjects. 

Tim Hammond from AstraZeneca underlined that preclinical studies in animals may be imperfect, but still represent the best way currently available to identify toxicity and to guide dose selection for first-in-man studies. "We would still conduct these studies even without regulatory requirements," he said. And for assessing reproductive toxicity and carcinogenicity, preclinical studies remain the only available means to assess risk, despite advances in alternative methods.  

From the perspective of the ethics committee, John Hudson of the UK Association of Research Ethics Committees noted the "increasingly uncomfortable" challenge of reaching decisions on the basis of increasingly complex—and voluminous—data, and deriving meaningful information for ethics committees and human volunteers to use in the process of informed consent. But in the end, he said, there is always a decision to be taken. "It has to be taken in as objective a fashion as possible, but ethical decisions will always be subjective decisions." 

Penny Hawkins from the UK Royal Society for the Prevention of Cruelty to Animals pointed to "a significant conflict of interest between animals and science." She insisted that the goal must be to alleviate human suffering without causing animals suffering. "That goal is a long way off, but we have to have a positive approach to achieving it," she said. 

From the patient perspective, said Cees Smit of the Dutch Genetic Alliance, what matters is the results of good research: "If that can be done without the use of animals, that's perfect. If animal experimentation is necessary, it must be humane and careful." 

Smit argued for greater involvement of patient groups in ethics committees, as well as an international research agenda that would reduce the number of animals used, with agreed methods so that alternatives to animal testing could be validated and internationally recognized. 

There was satisfaction at discovering some common ground among researchers, patients, and animal rights advocates, and between industry and policy makers, around the ethical principles of doing no harm to study participants, and of using animals only when unavoidable in the research and development of new medicines. 

While no "majority view" emerged, there were some useful contributions to thinking on the subject, and at least a list of items for further discussion in structuring the ethical agenda. Even the fact that it was possible to discuss such a controversial subject in such a broad, deliberately heterogeneous forum was greeted as something of a breakthrough—in itself an interesting measure of the almost febrile atmosphere in which medicines development takes place in Europe. 

As Neil Parish, a British member of the European Parliament and one of the cochairs of the meeting, said: "I get more letters and emails from people concerned about animal welfare than anything else I deal with." 

Among the broad areas of agreement, the participants at the meeting concurred on the key principle that less animal testing must not impact negatively on patient safety. There was also agreement that trial subjects must be informed about all relevant tests performed in animals and about what the results indicate about risks potentially connected to the administration of the new drug. In addition, any limitations of the tests in terms of their predictability of safety need to be pointed out. 

There was a general feeling that more harmonization of requirements both within the EU and among the EU, the United States, and Japan would help to reduce the number of animals used in experiments. Ethics committees considering first-in-man trials should have access to acknowledged first-in-man experts, it was agreed—in view of the obvious fact that a reduction in animal testing would put additional responsibility on ethics committees.  

But there were plenty of divergences too. The meeting indicated that some find the current regulatory framework appropriate, pointing to the low incidence of serious adverse drug reactions in trials. Others, however, feel that the regulatory requirements for doing tests in animals are not always justified, and urge continuous review of the current toolbox of experiments in line with progress in biomedical research—and, if appropriate, reduced rather than enlarged. 

But while it would clearly be acceptable to reduce animal use in cases where no suitable animal models exist, it is not at all clear how much animal experimentation is redundant now. This makes it difficult for trial sponsors, who might wish to stop doing studies in animals that are formally required but known to be useless in a particular situation. Since they have to justify whenever they diverge from the toolbox, regulators should offer more extensive guidance in early discussion with trial sponsors about animal studies, particularly through the scientific advice procedure that the European Medicines Agency provides. 

New regulations do work—sometimes. At the end of September, the European Medicines Agency made its first recommendation for the use of a centrally authorized medicine in children on the basis of trial data generated in accordance with an agreed pediatric investigation plan (PIP). This is the first example of the changes brought in by the European Union's recent pediatric regulation, designed to benefit children in Europe by promoting the availability of medicines specifically tested for their use. 

PIPs, one of the tools created when the new rule entered into force last year, are drug development plans for ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorization of the medicine for children. These plans must be agreed in advance by the Agency's pediatric committee, and are legally binding for companies developing products for use in the EU. 

Using the data generated as part of a PIP, Merck Sharp & Dohme applied for an extension of indication for use in children for its Cancidas (caspofungin), already authorized for the treatment of adults with severe fungal infections. The Medicines Agency adopted an initial decision on the PIP for Cancidas in February 2008 and a modification in May. The Agency's Committee for Medicinal Products for Human Use concluded in September that the data on the quality, safety, and efficacy presented support this extension. 

By coincidence, it was in September too that the EU published its formal guidance on the content of pediatric investigation plan proposals, and on how to seek waivers from the obligation to present a plan. This acknowledges that the "one-size-fits-all" guidance is bound to lead to some gaps in proposals, since the amount of information available "will differ substantially depending on whether a medicinal product is in early clinical development or already has a marketing authorization and is being investigated for new or extended uses."  

However, it does insist that where relevant information is available, it should be included in the application, "whether favorable or unfavorable to the product." This includes details of any incomplete or discontinued pharmacotoxicological test or clinical study or trial, and any completed trials concerning indications not covered by the application. Applicants are urged to consider whether there may be a therapeutic need for the medicinal product in each pediatric subset when they are drafting proposals. 

Just as important as PIPs is the subject of waivers from the obligation to present a PIP. Here the new guidance lays down that a waiver may be issued for one or more specified subsets of the pediatric population, or to one or more specified therapeutic indications, or to a combination of both, but only if there is a clear definition of scope in terms of pediatric subset and indication—and of route of administration and pharmaceutical form. 

There are very few free lunches in the guidance. Where the therapeutic indication and the subset of the pediatric population are already covered by a class waiver, no product-specific waiver is required, it concedes. But where only a partial class waiver exists, the product-specific waiver should clearly refer to the class waiver when specifying the scope of the product-specific waiver. In addition, companies are "encouraged" to inform the Agency's Pediatric Committee when new information becomes available, which suggests that a class or product specific waiver should be reviewed. Under such a welter of requirements, it will be no surprise to find many sponsors and investigators who feel they are drowning rather than waiving.  

 is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

View from Brussels

Animal use in clinical trials comes into question as Europe debates an update of current rules.

Europe Reviews Balance of Interests

Addressing the job satisfaction, benefits, and work-life issues for employees at any CRO is important because of the inherent client/service model and competitive market. As just one example of what is considered a large CRO, is publicly-traded ICON, which manages these needs for 6500 employees, with 71 locations in 38 countries. 

 spoke to John W. Hubbard, PhD, global president ICON Clinical Research, a division of ICON plc, about this Dublin, Ireland-based CRO's human resource philosophy and practice. 

In the United States, ICON offers a competitive compensation package in the form of base salary, bonuses based on accomplishment of personal objectives, and company performance, as well as stock option packages for management. U.S.-based health benefits feature medical, dental, prescription, and vision coverage with an employer contribution of 90%, and a 401(k) that is fully vested almost immediately with a company match. 

 John W. Hubbard, PhD, global president, ICON Clinical Research. 

Salaries for U.S.-based employees at ICON are determined through benchmarking against the health care, pharma, biotech, and CRO markets each year to establish base, mid- and high-level figures for each position. Placing within these levels is based on education and experience—ideally at the midpoint so there is room to grow without overextending the ranges. Overextension can create over-inflated numbers for certain positions, leaving a flat salary terrain when that job title is less in demand. ICON monitors the industry to make sure that its benefits focus on offering a competitive package including compensation, work-life balance, insurance needs, and a professional and aesthetically pleasing work environment. 

U.S. work-life benefits at ICON may include flex-time, paid vacation and sick time allowances for the care of children and family members, bereavement days, tuition reimbursement, compressed work week schedules, work from home programs, training programs, and annual charity drives. 

Hubbard said, "We're a good size, but we have a personal family attitude." ICON takes their employees input seriously with a global employee survey every two years that evaluates the company on these very issues. 

Salary and benefits are important, but workplace issues are also part of the whole job satisfaction package. Hubbard pointed to our own survey results that showed the overwhelming majority of respondents are "extremely/very satisfied" or "fully satisfied" with workplace issues, which we defined as workplace environment, technology needed to perform work, continuing education to stay current in the field, staffing levels, and workplace procedures and policies. 

"The right tools to do their job is very important. The good backbones at large CROs allow people to do the jobs that they need to do on a global basis. At ICON, I can go to any office and log on and get access to the network, whether I'm in Latin America, Singapore or China," said Hubbard. "When you are under tight deadlines and need reports, this is very important." 

Don't underestimate the value of a pleasant facility to come to work. "A well-lit area, with up to date computers and ergonomic furniture...these little pieces add up to job satisfaction," said Hubbard. 

 that the global business is growing in the high-double digits, especially in Asia, Eastern Europe, and Latin America. This high demand for experienced professionals creates significant competition in these regions and requires more management oversight with the clinical trials experience to mentor and develop this educated new staff. 

As a global CRO, ICON is very conscientious about monitoring parity of benefits across the countries in which it operates. It takes into account global business needs and goals as well as the specific local and cultural needs. This includes embracing the differences of country policy regarding health benefits, pensions, vacation, and holidays. 

It is has been widely published that cultures across the world place different value on personal time. It has been said that "Americans have lost focus of personal time vs. professional time," observes Hubbard. "Some countries through government initiatives and or cultural practices are better at balancing work life. All our employees work very hard, but in some regions time off is 'honored,' and we often see employees in these locations taking extended vacations allowing them to come back refreshed and reenergized and that has to be appreciated and respected," explained Hubbard. 

"There is a lot of pressure in this industry and our clients expect us to work long days and over weekends," says Hubbard. With these schedules, the most valuable benefit of all can be time. Recently, ICON gave U.S.-based employees an extra paid day off to balance additional health care costs passed on to the employees. "I received so many positive emails on that decision. People's personal time is so important," said Hubbard. To that end, the philosophy at ICON is flexibility. "We still have to get the work out of the door. But people need their time for personal issues and that has to be recognized," said Hubbard. 

What all this means—surveying the current workforce, benchmarking against other industries and their own, keeping apprised and evaluating employee needs and current work life trends—is that CROs go the distance to retain their employees. ICON has historically low turnover. However, Hubbard noted 2008 was exceptionally low for turnover, which he attributes to the combination of ICON's competitive, employee friendly work environment and the fluctuating economic climate. "People have a stable job that they like, so they stay where they are," Hubbard observed. 

Keeping its current talent becomes even more important for CROs who provide key strategic personnel for long-term drug studies. Losing a key team member can have short-term detriment to the sponsor's program. There is a lot of burnout in the industry because employees work very hard. But in the end, as Hubbard told an audience of IIR Partnerships with CROs conference attendees last April, "the people are in this industry because they care about health care and they care about what they are doing."—

A look into the work-life benefits that are offered at a large contract research organization.

Work-Life Notes from a Large CRO

Bringing with her over 15 years of clinical and research experience, 

 (Lancashire, UK) new medical advisor. Pawa previously served as the company's clinical director of the Lancashire Research Center.

, MBA, CPA, the current principal of Stratium Consulting Services, to the Madeira Board of Advisors.

 (Memphis, TN) new senior director of business development, after serving in the same position for 

 (Flemington, NJ) project director in clinical operations as of her recent promotion. In this position she will work to expand the company's oncology niche specialty. 

(Brussels, Belgium) new knowledge systems architect, where he will work to strengthen the company's technology and consultancy divisions. 

 (Cincinnati, OH) team as the new executive director and brings with him a strong background in bioanalytical technology, method development, validation, and sample analysis in pharmaceutical development. 

, a medicinal chemist experienced in drug discovery at large pharmaceutical and biotechnology companies, joins 

 (Toronto, Canada) as its new vice president of drug discovery. 

 (Hafnarfjordur, Iceland) has made a series of senior appointments including, 

 to executive vice president of third-party sales, and 

 to chief executive officer of Actavis, United States. 

 has been appointed as the new executive chairman and acting chief executive officer. 

 (New York, NY) new chief administrative officer, where she will be responsible for leading the expansion of the company's staff and internal operations as it advances its drug pipeline. 

With over 25 years of pharmaceutical and CRO experience, 

 (Research Triangle Park, NC) new vice president of business development and strategy. 

, MD, to executive director of medical affairs and strategic product development. 

, the recent managing director of commercial operations for 

 (St. Louis, MO), has been promoted to vice president of business development, imaging services. 

 (Dublin, Ireland) new chief operating officer, where he will manage the company's global operations. 

 on board as the company's new chief operating officer, after serving on 

 to the position of chief technology officer and 

 as vice president of global sales and marketing. 

, MD, president of the company's supervisory board, where he will be able to utilize over 30 years of academic and pharmaceutical experience 

Xcelience (Tampa, FL) brought four new people on board including, Omar Lamm, Dontae Solomon, and Robert Steitz as associates in business development, and Kim Black-Washington as director of marketing and strategic development. 

 (Newark, DE) clinical research unit—and 

 (Research Triangle Park, NC) have collaborated to create an integrated Cardiac Safety Service for sponsors.

 (Essex, UK) REACT short messaging service technology to enhance patient and subject recruitment and retention services for sponsors.

' (Cambridge, MA) Dataflow Manager, an automated trial management solution, for current and future studies in its pipeline.

In an effort to provide continuing education on electronic data standards for FDA reviewers, 

Clinical Data Standards Interchange Consortium 

(CDISC; Austin, TX) are collaborating to take on this education initiative.

 (Essex, UK) have together initiated a research program, where AbD Serotec's recombinant antibodies will be utilized by e2v to conduct feasibility studies showing proof-of-concept of e2v's proprietary biosensor system Visucare.

 (Tampa, FL) its "Outstanding Operational Award in Clinical Development," making the company one of 13 to be acknowledged at Merck's Annual Supplier Recognition Forum.

 (Buckinghamshire, UK) education manager, 

, has been awarded honorary membership in the 

Bulgarian Association of Clinical Research

 (Sofia, Bulgaria) after she trained over 75% of Bulgaria's research community over five years.

 (San Antonio, TX), a growth partnership company, acknowledged 

 (Redwood Shores, CA) as number one in North America for clinical trial management, based on the company's revenue and share in the industry.

  (Essex, UK) has been awarded the "Best IT Strategy Award" at the 2008 European Outsourcing Awards, where factors such as the effective deployment of the technology and its benefits to users were taken into account by the international judging panel.

 (Wayne, PA) has established its new Web site, 

. which utilizes blogs and discussion forums to draw attention to the company's subject matter experts. 

 (DUHS; Durham, NC) has completed a successful go-live of the 

(Fremont, CA) eResearch system, a clinical trials management system that will register all of DUHS' protocols and subjects for all cancer clinical trials.

Upon raising £1.25 million ($2.4 million) in a second round of investment funding, 

 (Newtown St. Boswells, Scotland) will use these funds for the final stages of development for its reformulated Selegiline transdermal patch.

Attendants of the Society for Clinical Data Management Annual Conference were provided with Windows Mobile hand-held PDAs on behalf of 

 (Baltimore, MD) has been given a fast track Small Business Innovation Research grant by the National Institutes of Health, which will provide the necessary funding for the company to develop its proprietary Web-based data management solution StudyCTMS.

 (Austin, TX) to provide training over the next two years to FDA reviewers on regulatory submissions.

 (Mountain View, CA) for approximately $57 million, under an agreement in which all of Pharsights' stockholders will receive $5.50 for each outstanding share of common stock.

In an effort to enhance its capabilities to offer Phase II-IV clinical trials support, data management, and biostatistics services in Eastern Europe, 

(New York, NY) have approved a merger agreement, in which Lilly will acquire ImClone for $6.5 billion. 

Business News

Industry news focusing on the people and organizations who work in the clinical trials profession.

Business and People Update November 2008

Over a year has gone by since the American College of Radiology (ACR) launched its for-profit division ACR Image Metrix (Philadelphia, PA) in February 2007. And based on its accomplishments thus far, it may be looking at even more success in the foreseeable future. 

"We're finding more imaging is being required to get drugs approved," observed Michael Morales, general manager of ACR Image Metrix. And, as imaging becomes more of a necessary —and valuable—requirement of clinical trials, ACR Image Metrix is benefiting from this trend in terms of the business generated from industry, which in turn has allowed it to double its goal of six projects for its first fiscal year. 

				While the need for imaging is certainly a part of the foundation in which the company's growth has stemmed, ACR Image Metrix was also born into industry with an existing level of credibility due to its sister organizations, the American College of Radiology (ACR) and the ACR Imaging Network (ACRIN).			

ACR, founded in 1924, serves its 32,000 members of radiologists, radiation oncologists, medical physicists, interventional radiologists, and nuclear medicine physicians by ensuring safety, accessibility, and efficiency of imaging. 

ACRIN is a research organization that was established in 1999. Its trials involve investigators from over 100 medical facilities within the United States as well as some international institutions. It has an archive of over 8 million images and has 180 sites both in and outside the United States, which ACR Image Metrix has access to. 

ACR has a core laboratory and three cooperative groups, including ACRIN, the Radiation Therapy Group (RTOG), and Quality Research in Radiation Oncology (QRRO). With an established professional organization and three additional cooperative groups, why might ACR want to launch a for-profit? 

 MichÃ¦l Morales, ACR Image Metrix general manager.			

"Government funding goes up and down," Morales explained, "and it might not be there for the future. So, ACR thought maybe we can form a community operation where all profits generated [from ACR Image Metrix] can go back into funding the three cooperative groups." 

"We're held internally to high standards because we want to uphold the reputation that the American College of Radiology has built," noted Morales. This solid foundation allows ACR Image Metrix to "tap into its scientific horsepower and its operational horsepower to accomplish what [it] needs to accomplish." 

Of the 12 projects begun in the first year, about 60% were global, Morales told 

. In order to ensure the most efficiency, images are dealt with electronically, providing a much faster transfer of information. 

This electronic transfer takes place through a "proprietary system called Triad that allows sites to download Web-friendly software. Sites can then upload deitemized images with patient data removed. Image Metrix incorporates analysis tools to analyze at a core lab," Morales explained. Thus, "when dealing with images we don't necessarily need someone on site." 

About 70% to 80% of the trials exist in the anticancer area, 20% in the musculoskeletal area, and less than 5% in cardiovascular. "There has been an explosion of research in anticancer areas in comparison to other therapeutic areas," noted Morales. 

Though anticancer research dominates, Morales expects an increase in the musculoskeletal area simply because more imaging is being required in clinical trials. He also sees potential for the cardiovascular area to increase because ACR Image Metrix is looking to partner with iCAD (Nashua, NH), a provider of computer-aided detection solutions that assist health care professionals in analyzing images. 

Exceeding its goals for the first fiscal year, the company is now looking ahead to an even more productive second year. Morales noted, "One of our goals is to add an additional 18 projects and we are at our goal for the first two and half months, so we are on track to attain [it]. Second, we want to be positioned as a market leader in this category...And third, we want to make sure we exceed our clients and sponsors' expectations."—

News

ACR Image Metrix doubles its initial goal for its first fiscal year.

First Year For-Profit Finds Big Success

Work-life benefits are critical in any industry and when it comes to the success or failure of a clinical trial, where ultimately millions of dollars and the quality of life are at stake, CROs are no exception. While it may not be definitive how much an employee's job satisfaction affects his/her performance at work, there is undoubtedly a correlation between the two. 

So, how can employers effectively implement a series of work-life benefits that will fully satisfy an employee and in turn promote the best job performance? 

 spoke with Jodi Andrews, founding partner and chief executive officer of ProTrials, a small CRO based in Mountain View, CA, about the types of work-life benefits her employees receive and the underlying belief system as to why they are offered. 

 Jodi Andrews, founding partner and chief executive officer of ProTrials. 

With 75 employees, ProTrials offers a standard benefits package, including health care, dental, 401(k), and the basic vacation and sick time. In addition, they are also offered tuition reimbursement, which allows employees a certain amount of money per year for training or courses relevant to the job. 

Each employee's salary is based on a structured salary range specific to a job family. "An employees' salary is determined on their years of experience and how that compares to others in the job category," Andrews noted. 

Raises take place annually and are based on each employee's individual performance. While there is a range each year for bonuses, these are effected by the health of the company. 

Known for its 90% retention rate, ProTrials takes advantage of its smaller size as a CRO and looks to provide its employees with benefits that larger companies would be unable to offer. "Most people have flexible schedules here," Andrews noted. 

"Something that works for us as an organization is we allow people to come in early and leave late if they need to." People are also able to work from home when necessary and numerous employees work part-time. As a company, "we are sensitive to not being clock watchers—if someone needs to leave to go pick up their kids, they can leave," Andrews explained. 

"We are smaller so we are able to have...more flexibility. As owners we have a lot more interaction with employees," Andrews said. Flexibility is "important in CROs because it tends to be majority women based. For us it's more important to get the job done and get it done well." 

As a woman-owned business and a member of the National Association of Women Business Owners, one of ProTrials' goals is to promote work-life balance. "One of our core values is balance between family and work life, we know people have to have both. In the CRA world a lot of the time it's all about travel, and that's hard with families," Andrews explained. 

Beyond these various benefits ProTrials also offers employees opportunities to give back to the community. The company allows one day off per year to volunteer and do charity work. 

The company gives back to the environment as well. ProTrials was certified as a green business in 2007. Highlighting its green initiatives: Employees are offered hybrids when renting cars and the option to plant a tree every time they take a flight. 

In CROs, employees are often spread out, making it difficult for members of a team to become acquainted. In an attempt to alleviate this issue, the company holds an annual party where people are able to bring their families and spend a weekend with other employees. "We certainly want to promote the teamwork aspect and getting to know your fellow employees," Andrews said. 

"I hope and believe that people think we do care about them," Andrews said. "If employees are happy they'll do a 

A look into the work-life benefits that are offered at a small contract research organization.

Work-Life Notes from a Small CRO

Send your new product info to: Kerri Nelen, 

Enterprise Document Management for the Lab

Collaborative agreement calls for product bundle for laboratories 

 (King of Prussia, PA) have entered into an agreement whereby NextDocs Document and Compliance Suite will offer an extension of Thermo Fisher Scientific's laboratory information management systems (LIMS) and chromatography data systems (CDS) products.  

The product will be sold by Thermo Fisher Scientific under the NextDocs name and will offer fully integrated informatics and a content management solution that complies with FDA 21 CFR Part 11, GMP, GLP, GCP, and other regulation and industry standards. 

The NextDocs suite is built on the Microsoft SharePoint 2007 platform. 

Thermo Fisher Scientific, (781) 933 4689,  

Product Registration and Labeling Integrated

Solution addresses life sciences end-to-end global product tracking

(Toronto) have integrated their products: ALiCE 4 Labeling (A4L) from i4i and Aris Global's Register.  

 Aris Global and i4i joint product manager 

A4L is an XML-based product label and authoring application, while the Register solution offers a central repository for managing the end-to-end tracking of global product registration details and submissions. The integrated applications will provide a comprehensive solution for centrally managing products, tracking and planning global registrations, and addressing all authoring and lifecycle management aspects of e-label production. 

The joint solution enables organizations to manage and track updates and variations to determine any regulatory impact of proposed changes.  

Module targets data management and transfer for teams

 (ISI) (Whippany, NJ) announced its new module—ISI Submission Manager (ISM)—to its integrated regulatory solution suite. The module targets metadata and the relationship between submissions and allows regulatory teams to manage and transfer data between submissions, as well as create reports based on submission status from eCTDXPress and ISIPublisher, ISI's products that manage eCTD, paper, and non-eCTD electronic submissions. The suite is now integrated on a single platform. 

There are two key components to ISM. The first allows users to access outline views for all of the eCTDXPress applications/submissions. The second component, Metadata View, allows users to view hierarchy, Regional, ICH, STF, and custom metadata associated with each publication or submission. 

eShowcase

The latest eClinical software in the clinical trials industry.

eClinical Software: November 2008

It is no secret that the pharma industry is experiencing a particularly bad patch. A simple reading of the numbers tells the story. In 2007 FDA approved just 17 new molecular entities (NMEs), the lowest number since 1983. Obviously the industry's R&D engine is lagging. Companies are just not able to fill their pipelines with drugs that won't fail at the last crucial hurdle. While the industry spent $3.2 billion on R&D in 1983, that figure grew to $43 billion in 2007. This means that industry spending per approved NME increased from $228 million in 1983 to $2.5 billion in 2007. These figures, read together, tells us that something needs to be done and done immediately. 

At the center of the issue is R&D productivity. Today's trials are more complex, involve more people, and are often geographically spread out. Needless to say, they are more expensive. Yet, the need to hit the market first is more acute: While the first brand in the market captures 40% to 60% of the market, the second manages only around 15%—and being third means negative business. 

Of course, there is no silver bullet to solve the problem. However, there are some obvious steps the industry must take to emerge out of the current impasse. 

One step is to standardize data and protocols to enable interoperability. Though CDISC has been around for nearly 10 years, the industry is yet to fully adopt its standards. Implemented at the beginning of a study, CDISC standards are estimated to provide savings of 70% to 90% on start-up time and cost. And standard protocols will allow semantic interoperability. 

Second is the dependency on paper-based processes. Not only do they prolong study time, they also cost more and can introduce errors. Paper intensive processes have been the bane of other industries, like banking and insurance, which have gone on to eliminate paper. Similarly, the pharma industry needs to redesign trial processes for efficiency and then automate where possible. 

With many companies and research centers emphasizing translational research—lab studies that are brought almost directly to small cohorts of patients to test hypotheses of improved diagnosis or therapy—the need for collaboration between the various disciplines and stakeholders is becoming crucial. For effective collaboration, data standardization, integration, and interoperability are essential. 

Information management is another important area in which pharma companies need to pay attention. The entire clinical development process generates an enormous amount of data, which is not efficiently used. If this information is integrated with that from the discovery phase and postmarketing studies, companies can tease out important insights that could result in new drugs or help avoid costly failures. 

To sum up, scientists and clinicians are trying to implement next-generation approaches to drug discovery and development using last-generation technical infrastructures, business processes, and rules. Tomorrow's successful companies will form governance bodies at the highest level, do their homework to understand the dimensions of the problem, prioritize corrective action into a multiyear playbook, and bring their operational practices into the 21st century. 

A Closing Thought

The need for collaboration between the various disciplines and stakeholders is becoming crucial.

Welcome to the 21st Century

Success rates within drug development vary by indication, with CNS drugs averaging lower than many other categories. There are many contributors to drug trial failure, but in CNS, in the clinical trial phase, methodology using subjective assessments could be a major cause. The Foundation for Improving Data Quality (FIDQ) was recently formed to advance the evaluation of clinical trial methodologies that aim to improve the clinical integrity and reliability of clinical data. The Foundation is particularly focused in those disease areas where subjective measures—clinician rated and patient reported outcomes—represent pivotal study endpoints. 

				The FIDQ is governed by CNS research experts chosen for their specific expertise in psychiatry and neurology (see sidebar). Amir Kalali, MD, vice president, medical and scientific services, global therapeutic group leader for CRO Quintiles, told 

The Foundation for Improving Data Quality (FIDQ) advances the evaluation of clinical trial methodologies that aim to improve the clinical integrity and reliability of clinical data.

Applied Clinical Trials-11-01-2008

The Changing Role of Data Services Project Managers

Europe Reviews Balance of Interests

Work-Life Notes from a Large CRO

Business and People Update November 2008

First Year For-Profit Finds Big Success

Work-Life Notes from a Small CRO

eClinical Software: November 2008

Welcome to the 21st Century

Foundation Tackles CNS Trials

The Changing Role of CRAs

A Global Regulatory GPS?

EU's Pediatric Regulation Sees First Approval

Work-Life Notes from the FDA

India's Talent Crunch