10 Ways to Reduce the Risk of Comparator Drug Sourcing

As a population, we have greater access to information than ever before. Couple this with challenging economic times and the result is an environment in which things are no longer accepted at face value. This trend is impacting all industries, including drug development. 

(PHOTOGRAPHY: GETTY IMAGES   ILLUSTRATION: PAUL A. BELCI)

Given this climate, intensified interest in comparative trials should come as no surprise.

  Economists, insurers, health care professionals, and the public seek more compelling evidence on how drugs compare in safety, efficacy, and cost. At the same time, governments around the world are promoting the use of comparative effectiveness trials in an attempt to control the inflation of health care costs and provide additional information in support of the approval process (see sidebar). 

Investment in these trials is expected to increase as companies seek to better demonstrate the value of new therapies and make the case for inclusion in hospital and government formularies and reimbursement under insurance coverage. 

Comparative effectiveness studies for new drugs, however, are not yet commonplace. Most often, clinical trials compare investigational drugs to placebos rather than subjecting the drugs to rigorous evaluation against existing treatments. While comparison against a placebo is generally required by regulatory authorities, trials must also include an active comparator when a pharmaceutical company seeks to claim superiority versus the competitor drug in its marketing materials; or an active comparator may be the only control agent in cases where giving trial participants a placebo would not be ethical. 

As pressure mounts to conduct comparative effectiveness trials, pharma companies must put in place robust strategies to first select a comparator drug and then source and supply that drug in an uninterrupted manner to all trial sites. 

Sourcing and supplying comparator drugs for global clinical trials presents a number of obstacles and potential pitfalls for the trial sponsor. 

The inability to obtain the necessary pedigree and product documentation for the comparator, lack of supply chain security with possible introduction of counterfeit comparators, and delays in resupply throughout the course of the trial are some of the problems that can lead to significant operational, regulatory, and financial setbacks for the trial sponsor. As such, drug developers must have a comprehensive view of what is involved in the process and formulate a customized, strategic approach to best support their trials. 

To minimize the risk of delayed or interrupted clinical trials and the financial implications that can result, a comparator sourcing and supply strategy should include a number of elements. These include demand planning that can accommodate changes in the quantity of comparator drug needed in light of fluctuating patient enrollment or unexpected changes to a trial; changes in regulatory opinion, or temporary or permanent regulatory noncompliance by the source manufacturer; loss of the project's consulting global regulatory expertise; changes in global sourcing capabilities and logistics; and loss of connection to the comparator manufacturer via a sourcing specialist. 

Exposure to operational, regulatory, and financial risks can increase if comparator sourcing is considered a series of transactional events (e.g., buying a comparator from a wholesaler as needed) rather than a process requiring a well thought-out strategy. In situations where sourcing becomes an afterthought amidst all of the other trial requirements, a transactional approach vs a strategic approach to supplying comparator drugs can jeopardize the progress of a trial. 

Probably one of the simplest ways to reduce risk during the comparator sourcing process is to start planning early, typically during the protocol design phase. 

A head start on planning is imperative, as comparator drugs are likely to be available from a wide variety of sources across a number of geographies. Each source, however, may exhibit regional variations and will be governed by different trade regulations, all of which must be considered prior to selecting the most appropriate source. 

Properly assess options, availability, and limitations for sourcing the desired comparator

Evaluate regional variations of comparators, including dosage form, strength, API concentration, visual aspect, and  intracountry regulatory agreements related to the equivalency of different comparators

Review sourcing options for regulatory requirements, packaging, reformulation, blinding, and relabeling needs

Establish required volume/quantities and delivery schedule

Evaluate price and total cost of acquisition of comparator

Confirm availability of required pedigree and product documentation.

The ultimate goal of comparator sourcing is to get the right drug to the site at the right time. Indeed, the efficient management and movement of trial supplies, including comparator drugs, is an important factor in the success of any trial. 

Making this process more challenging is the growing number and increasingly global nature of clinical trials. Significant growth in the number of clinical trials conducted is expected in many regions, in particular: Africa, the Middle East, Eastern Europe, and South America.

  A recent benchmark study by Bearing Point and AMR Research on the clinical supply chain found that only 38% of respondents' trials would be conducted within North America and Europe.

An expanding number of trials and their geographic diversity place an added burden on both regulatory and supply/logistics teams to establish and maintain a compliant, efficient, and secure supply chain across many borders. 

Requirements established by local regulatory agencies regarding the source of comparators (i.e., whether a comparator sourced in the United States can be used in an EU-based trial) as well as general trade regulations governing import and export must be understood and followed. Further complicating supply and logistics are comparators that require special handling, such as cold chain requirements, controlled drugs, or those that involve complex, small dosage forms. 

All of these factors are converged to put additional pressure on the supply chain, and if not managed effectively can result in delayed delivery of the comparator to the site, which in turn, can lead to costly delays or trial interruptions. 

An agile, global inventory and logistics management process supported by extensive regulatory expertise is more critical than ever to ensure compliance, supply chain security, prompt delivery of comparators, and global batch traceability in the event of a recall. Regulatory expertise specific to the countries the comparator is being shipped to also helps ensure that proper documentation accompanies the drug. 

It is therefore critical that trial sponsors remain updated on and attentive to the constantly evolving regulations affecting the geographies in which trials are running and also maintain close relationships with key regulatory bodies and customs should sourcing related questions arise. 

Once the desired comparator has been identified for the trial, the task turns to locating an appropriate source or sources for the drug. While the comparator may be available from a variety of sources, regional variations in the drug itself such as dosage form and strength, API concentration, and visual aspect make it important to have as broad a view as possible of available sources across many geographies. 

Detailed knowledge of the global comparator sourcing landscape enables assessment of a range of options, leading to selection of the most appropriate, reliable, and reputable source for a particular clinical trial. 

Caution must be exercised, however, when evaluating sources for a comparator. Only those sources that are audited to ensure supply chain security and minimize the risk of counterfeit products should be considered. 

Global sourcing capabilities also enable rapid identification of alternative sources for a comparator should there be an unexpected change in production or formulation of the original source material. Immediate access to information on alternative sources helps minimize the possibility of delays in delivering comparator drugs to trial sites. 

Probably one of the most effective ways in which the risk can be taken out of the sourcing process and ensure comparator availability throughout the course of the trial is to source directly from the comparator's manufacturer. This direct route can be problematic, however, as most trial sponsors wish to maintain anonymity during the sourcing process. It should also be noted that a comparator's manufacturer may have no interest in making a drug available to a sponsor seeking to prove superiority of their compound. 

Trial sponsors can leverage this direct sourcing route while preserving anonymity through partnership with a sourcing specialist that maintains extensive relationships with manufacturers and can negotiate on the sponsor's behalf. Working with a specialist who has such connections also brings additional benefits beyond confidentiality. 

A sourcing specialist can liaise directly with the manufacturer to schedule production runs to meet both short- and long-term comparator requirements. This demand planning helps ensure reliability of supply throughout a trial with the same quality of material and can help maintain flexibility of supply should comparator requirements change due to a study being extended or through fluctuations or delays in anticipated patient enrollment. 

In addition to effective demand planning, sourcing directly from a manufacturer enables access to large, single lots of the comparator with maximum shelf life, and specific batch numbers when possible. Securing comparators with a lengthy shelf life provides time for characterization, demonstration of bioequivalence, relabeling and repackaging, if needed, while minimizing the frequency of costly resupply. 

Securing the proper paper trail for the comparator can reduce exposure to risk, and this is much easier when dealing with the manufacturer. The manufacturer can routinely provide full pedigree documentation reflecting the chain of custody from the source to your designated point of delivery along with full product documentation, including certificates of analysis, certificate of conformity, package inserts, GMP compliance, equivalency data, material safety data sheets, and TSE/BSE documentation. 

The availability of these documents is not guaranteed when sourcing comparators via wholesalers, putting a company at risk in terms of meeting regulatory requirements. While a wholesaler may be able to offer the lowest product cost, the lack of robust relationships with manufacturers and supply quota restrictions may result in an unreliable supply of comparator throughout the course of a trial, ultimately leading to a much higher total acquisition cost. 

Many sponsors are interested in the concept of single sourcing, which is the supply of a comparator drug from a single geographic source to sites in multiple countries. When considering single sourcing in support of a trial, it is important to weigh the pros and cons associated with this strategy. Single sourcing offers a number of benefits to the sponsor including:  

Articles

Feature Article

Effective ways for sponsors to reduce risk when embarking on comparative clinical trials.

Strategic Comparator Sourcing

While security of employment remains uncertain, it seems clinical trials professionals are becoming more interested in taking control of their own destiny—at least as it applies to their career. 

Clinical Trials Professionals on Contract-Based Employment			

A recent survey conducted by Red Tree People Ltd. (Cheshire, UK) shows that 60% of clinical research professionals have considered becoming a clinical research contractor at some point in their career, and 44% would actually consider making the move. 

As some would simply attribute these survey results to the current economic conditions, respondents noted the most important factors in deciding to become an independent contractor as higher pay and rewards (39%), flexible working (36%), and feeling of independence (20%). None cited the fear of job loss.  

"As you might expect this was offset by inhibitions for job security and the retention of company related benefits," Andrew Baillie, director of Red Tree People Ltd., observed when reflecting on the previously mentioned statistics. 

Preemptive strikes against the narrowing job market may not be the driver toward independent contract-based employment, but it could possibly be why employees have yet to make the move. 

Of those respondents that realized this trend was taking place among their colleagues, they found that a recognition of opportunity (44%) was the primary driver. 

Following down the path of embracing contract-based employment, PharmaNet (Princeton, NJ) has launched PharmaNet Resource Solutions—a new business entity dedicated to providing industry with "consistent quality-driven flexible resource solutions." The company provides services including on-demand staffing, strategic alliances, functional service staffing, and quality control/study rescue management. 

"Historically, [PharmaNet] has made limited use of contractors. The Resource Solutions business is a new service offering to clients, and will also be utilized internally to accommodate rapid swings in resource demands," explained Susan Seroskie, vice president of PharmaNet Resource Solutions. 

Similarly, Quanticate (Cambridge, MA) has designed Quanticate People with the intention of placing candidates in roles that they are best fit for rather than any position that is open at the time. These contract-based employees receive payment once the customer compensates the company. If the project calls for it, Quanticate also provides appropriate training for these independent contractors. 

Whether this seemingly emerging trend is a byproduct of the unstable economic conditions, or industry is simply taking greater advantage of an underutilized employment infrastructure, its implications will begin to take flight. 

"A move towards independent manpower provisioning would serve all parts of the marketplace as the burden of employment would be taken up by individuals. Both pharma and CRO will be able to access the talent pool on demand," noted Baillie. 

Undoubtedly moving from a full-time, or even part-time position to one that is independently contracted would require some sacrifices. 

A respondent stated, "The desirability of self employment depends on the level of risk, uncertainty, and stress, and the greater responsibility that the individual can handle, balanced out by greater flexibility and potential earning. Employment gives more human and technological support, including training, structures for personnel development. There are human needs that are met differently by the two options (e.g., comradery, belonging versus independence, etc.)." 

It remains to be seen whether the economic standing of the clinical trials outsourcing industry is driving its professionals toward independent employment, or if this trend indicates people are simply moving forward with a career opportunity. 

News

A survey says independent contracting is gaining popularity among clinical trials professionals.

Path to Self-Employment

Product includes claims data for site identification

 announced its Web-based, clinical trial and data management system i3Cube. i3Cube offers additional data mining into health care claims data to help users target investigators with appropriate patient populations, as well as determine the sites and patients that best match protocol criteria for studies.  

Other product benefits include intuitive user interface, customized reporting, automated workflow, collaborative communication portal, single document repository, and informative dashboards. These dashboards summarize all clinical trial information at a high level, with drill down for specifics. Access rights to the clinical trial information are determined by role, i.e., CRA, project manager.  

Small to Midsize Business Needs Addressed

Hosted solution manages, analyzes, reviews clinical trials data

 announces its Solution OnDemand: Drug Development for the small to midsize businesses that help review clinical trials data in order to determine safety and efficacy outcomes. The Web-based hosted solution aggregates, analyzes, and reviews clinical trials data. The solution also includes a compliance-enabling platform for developing, executing, and managing the collection, sharing, transformation, analysis, and submission of clinical research data. 

This application basically addresses limited IT infrastructure and resources of smaller companies. It features secure access for internal and external user communities, which can include CROs, collaborative development partners, and monitoring committees. Also, as a hosted solution, there are no direct hardware or software installation, systems administration, validation or maintenance costs. 

Social Networking for Clinical Research Patients

Application addresses both recruitment and clinical trial awareness

announces its new social networking application Click it Forward. The company developed the application for the two most popular social networking platforms, Facebook and MySpace.  

People register and install the free Click it Forward application on their Facebook or MySpace page and then spread the application exponentially by inviting online friends to install it. The user then gains points, which translates into the amount of money Acurian will donate to the preferred medical causes the user selects. The application also integrates Google Earth so users can see a visual map of their own Click it Forward network. 

eShowcase

The latest eclinical software in the clinical trials industry.

eClinical Software: April 2009

The use of CROs, an expanding multibillion dollar business, is expected to continue its growth in the coming years.

  And since overall R&D costs and productivity represent one of the most pressing issues industry leaders face today,

  outsourcing will almost certainly continue to play a major role in drug development. 

(PHOTOGRAPHY: STEPHEN E. MUNZ   ILLUSTRATION: PAUL A. BELCI)

The University of the Sciences in Philadelphia (USP) and TTC, llc are conducting a multiyear research program on the factors associated with improving the speed and cost effectiveness of clinical studies, including the role of outsourcing. 

Our research study includes a Web-based survey of sponsor pharmaceutical companies and CROs in a range of areas, from how CROs are used to the process of selecting and managing a CRO. Other papers in this project have addressed a number of these CRO-related topics.

In this study, participants identified two related, yet distinct, outsourcing management areas: selecting a CRO and managing a CRO. 

We found that a company that considers itself as performing well in managing a CRO tends to believe that it is good in the previous step of selecting a CRO. Similarly, companies skilled at CRO selection also consider themselves to be especially competent in the management processes that lead up to selecting a CRO, such as using a common bid grid. However, the reverse does not hold true. Respondents in companies that consider themselves effective in selecting CROs do not necessarily assert that they are adept at the subsequent step of managing a CRO. 

Managing outsourcing involves many areas and processes. This study examined four key outsourcing-related activities: annual budgeting, the use of bid-grids, CRO selection, and the management of outsourced projects. 

The annual budget sets the operational parameters for almost every organization. Tracking and understanding operational variances from budgeted numbers is a demanding task, both for those who collect the numbers and for those who make decisions based upon those numbers. 

Yet few sponsor company participants in this study thought their ability to budget annually for outsourced studies was more effective than their counterparts' in other companies. But even fewer considered their company less effective than competitors in the budgeting process (see Figure 1). 

As one senior outsourcing manager put it: "Budgeting is something we need to get right, but often do not. Many times, though, it is really because the scope of the project changed, and no company will ever be able to anticipate all the changes. We could still do a better job of budgeting...particularly because no one likes having to go back for more money." 

There is a large variation in the way study participants evaluated their company's ability to select CROs, a greater variation than we found in their responses to the use of budget and bid grids. Although most participants felt that their company was similar to others in its ability to select a CRO, a third of those surveyed thought their company was better than other companies in selecting a CRO. At the other end of the spectrum, fewer than one in 10 considered their company to be ineffective in selecting a CRO. 

Apparently, the ability to effectively select a CRO is not concentrated in any particular pharma company, whether large or small, or limited to a particular geographic area. 

In addition, companies who consider CRO selection a competitive strength do not outsource an appreciably greater percentage of clinical development work. Moreover, these companies use CROs in much the same way: as preferred providers, full service providers, functional providers, single area outsourcing, or insourcing (see Table 1). 

Both sponsor company and CRO participants evaluated the importance of the set criteria many pharma companies use in selecting a CRO. Generally, while all participants strongly agreed on the selection criteria, some thought particular criteria were more important, while a smaller number of respondents cited very specific criteria as being most important. 

CRO selection criteria deemed most important were: the team's general sense they can work with the CRO, and a project management team devoted to the study. The criteria judged least important included: CRO invoicing/billing processes, and being one of the largest 20 CROs. 

Overall, companies that consider themselves better at selecting CROs generally use the same selection criteria as companies who do not consider themselves as adept at it. Still, depending on the type of company surveyed, there were important differences for a few of the selection criteria. 

For example, larger sponsor companies emphasize a CRO's size and geographic capabilities more than smaller companies. American pharmaceuticals value the mechanics of issue identification and resolution more than their European counterparts. Examples of these mechanics include a CRO's willingness to accept penalty clauses for poor performance, and an established process within a CRO to bring project problems to the attention of senior CRO managers. 

American participants were also likely to stress the detailed operational components of the CRO's approach. A case in point is the project execution plan the CRO presents in the bidding process, including items such as resources, country, and site selection. 

Respondents located in Europe, or from smaller companies, felt they were somewhat or clearly better than other companies in managing CROs. More Europeans than Americans (52% vs 31%) believed their company was better than others in managing CROs. Smaller pharmaceutical company respondents were more likely than survey participants from the largest 20 companies (54% vs 40%) to think they were better than others in managing CROs (see Figure 2). 

The European sense of being better at managing CROs may come from how they view CROs in total, and how their views differ from the American perception of CROs. 

For example, European participants are less severe in the evaluation of CROs on a series of operating dimensions (see sidebar). They were more likely to give CROs the benefit of the doubt in a range of areas such as communication problems, motives, and commitment to quality work. 

Operating Dimensions used to Evaluate CROs 

Americans and participants from larger companies were more likely to question CROs than were Europeans and respondents from smaller sponsor companies. Americans, especially in larger companies, often thought that the CRO would be more focused on getting the next project than performing well on the current project. 

Americans were also less likely to concede that the sponsor may often be the source of the communication problems on an outsourced project. And Americans were more prone to think it is more expensive to do work with a CRO than to perform the same work internally. 

Pharma company participants in this study report that, on average, their companies spend 27% of total CRO expenses on overseeing CRO projects. And there is no statistically significant difference between the better and poorer managers of outsourced work in the amount they spend on oversight. 

Nor are the companies who consider themselves better at managing CROs more likely to use fixed price contracts; they used fixed priced arrangements for 39% of their CRO contracts compared to 38% for the other companies. 

Similarly, there are no significant differences in the average amount of final budget variance due to scope changes (14% and 16%), or variance due to factors outside of changes in scope (12% and 11%). 

Companies that consider themselves better at selecting CROs also view themselves as better at major activities immediately prior to the final selection of a CRO. 

These companies are better at annual outsourced budgeting and use a better bid grid. They also use CROs with some slight variations: They make greater use of insourcing and draw less on full service providers. 

Study participants from clinical operations and contract management/finance rated their companies slightly higher on selecting CROs than did individuals from other corporate areas. This is likely due to the fact that they are more directly involved in areas related to selecting a CRO, such as using bid grids and annual outsourcing budgeting. However, in the final model a respondent's functional area was not significant. 

Respondents who consider their companies to be better at managing CROs are more likely to come from smaller pharmaceutical companies, be located in Europe, and perceive themselves as better at selecting CROs. Additionally, they see their use of preferred providers declining over time. 

Both groups—those who do and do not think they are better at managing CROs—share similar attitudes about how CROs operate and how the sponsor company should interact with the CRO. These shared attitudes include:  

The importance of a working partnership between a CRO and the sponsor company

The extent to which a sponsor company must closely monitor the details of a CRO's performance

The belief that CROs look for every way to increase billing on a given project, even at the expense of quality. 

However, the self-identified "better managers" of CROs tend to take a broader view of communication problems in outsourced projects. These better performers are more willing to acknowledge that communication problems are likely to originate with the sponsor company. Companies that are better at managing CROs also think they are better at selecting a CRO. But they do not necessarily think they are better at budgeting or using better-quality bid grids. 

Project managers and individuals in clinical operations are more positive in their views of how their companies manage CROs. But, once again, functional area did not appear as a statistically significant variable. 

Clearly, individuals may think their company is particularly good at the steps involved in outsourcing, but generally respondents—regardless of their functional area—identified two key decision loci: CRO selection and CRO management. 

Every company must critically evaluate itself on the individual dimensions it considers critical in managing outsourcing and develop steps to bring its actual practice into line with expectations. This process can include tools and information to better manage budgeting, the RFP process, and bid grids, and to better select and manage CROs. 

Study reveals how sponsors rate their own outsourcing abilities compared to other companies.

CRO Selection & Management

As a light on the gray horizon, so shines the upcoming Biotechnology Industry Organization (BIO) International Convention, otherwise known as BIO 2009. 

A little dramatic? Perhaps, but when most biotech stories today—outside of the recent $46.8 billion Roche/Genentech acquisition—tell tales of woe and depleted company bank accounts, an opportunity like the one in mid-May in Atlanta offers hope. It's a rare chance for thousands of professionals from around the world (BIO looks to match last year's 20,000) to meet up face-to-face and together figure out a positive way forward. 

"I think the networking, the discussions, and the meetings that will happen will all be around: What's the new business model? How are they [companies] finding funding? What are they looking for?" says Robbi Lycett, vice president of conventions and conferences for Washington, DC-based BIO. "I think that will be the focus in every discussion regardless of the session." 

That includes those related to clinical trials as well. Although the questions will be different, the theme will be the same: What's the best business model moving forward? To this end, many sessions will highlight ways to improve efficiency and decrease costs—whether discussing subject recruitment or global outsourcing. 

One session that will focus on this theme is Adaptive Research in Practice, led by Michael Rosenberg, MD, president and chief executive officer of Durham, NC-based Health Decisions. Dr. Rosenberg, a third-time presenter and passionate proponent of the adaptive approach, says his session aims to equip attendees with valuable practical insight.  

"I hope they'll come away realizing there is a faster, less expensive way of developing drugs than what they're used to," he said, attributing adaptive approaches with reducing trial times and expenses by 10% to 25%. 

For the second year, the conference will include a Clinical Trials Pavilion—one of 70, and the second largest with 28 exhibitors. In terms of growth, Eric Misic, conventions and conferences, BIO, estimates an approximate 20% increase in square-footage over 2008. 

The Pavilion is part of the "Clinical Trials Zone" (there are 11 different Product Focus Zones) and will host a range of companies that fall under the clinical research umbrella, including CROs, subject recruitment firms, data management providers, manufacturers, and imaging labs. 

The idea for a pavilion came about after attendee feedback revealed that locating companies on the bustling show floor sometimes proved difficult. So, "instead of searching for a needle in a haystack, they're able to find exactly where these companies are," said Misic. 

Hopefully with the same ease, answers to the challenges facing industry will also be found during the convention. That would certainly meet BIO's expectations for this year's event. According to Lycett, the goal is that "the industry comes away from this meeting with ideas and business deals...that will help our industry get through the rest of the year and 2010." 

For more information on the upcoming 2009 BIO International Convention in Atlanta, GA, May 18-21, visit 

May convention provides golden opportunity for industry to collaborate and to strategize for a better future.

BIO Breeds Hope

 will now serve as the vice president of global operations, sales, and marketing for 

 (Indianapolis, IN), adding to her prior responsibilities: operations, logistics, sample handling and processing, and IT.

 now the vice president of global finance and human services for 

• Taking on the responsibility for the scientific services provided to 

will serve as the company's new chief operating officer.

• As the new vice president of clinical development and chief medical officer for 

, MD, will be responsible for research services and clinical development. 

• After a lengthy career at Genzyme as general manager, 

 (Leiden, The Netherlands) as its new chief executive officer. 

 as the director of analytical chemistry and 

 (Cambridge, MA) new president of U.S. operations, 

 will support the company's existing and new U.S. clients, and continue to direct global sales. 

• With previous senior level positions in corporate development, operations management, business development, and sales under his belt, 

 (Billerica, MA) new chief operating officer. 

, a 20-year veteran of the clinical trials industry, has released his latest book, 

Guide to Drug Development: A Comprehensive Review and Assessment .

• Continuing toward its goal to double its staff in the next year, 

 (Baltimore, MD) has added three statisticians to its team: 

• Bringing with him more than 30 years of experience in the area of clinical trial supplies and processes, 

 will now serve as the general manager of EU Operations for 

 (Ruggell, Liechtenstein) is expanding its Scientific Advisory Board with the addition of 

, MD, all of whom will utilize their experience to strengthen the company's expertise in transdermal delivery of drugs. 

• To support the expansion of its global CNS Rater Services Department, 

• A growing customer demand for postmarket studies has led 

 (Princeton, NJ) to expand its project management and add 

 as project directors of clinical operations for periapproval services. 

[Left to Right] Richard Ennis, Ulster Bank (awards sponsor); Martin Lamb, Almac; and Rotha Johnston, Invest NI.

 will serve as the new president and chief executive officer of 

 (Roanoke, VA), where some of her new responsibilities will include implementing solutions, driving partnerships, and overseeing initiatives around innovation. 

• As the new vice president of North American sales for 

 will be responsible for developing and leading the sales team in oversight of sales operations, processing, and training. 

• Two software and life science industry veterans, 

 (Holmdel, NJ) executive leadership team. 

 (Sunderland, UK) will allow Expression Analysis to offer its services and gain access to clients within the UK market.

 (New York, NY) Medidata Rave as its data management solution, the Seattle Children's Research Institute's

 (CFFT) will use this integrated solution of electronic data capture and clinical data management and reporting for several upcoming cystic fibrosis clinical research trials.

 (East Hanover, NJ) to identify new drug targets and therapeutics across various disease areas.

Aiming to identify and validate biomarkers for the assessment of drug toxicity, 

 (Rockville, MD) have collaborated to share each other's knowledge and resources in this area.

To achieve best practices for clinical research infrastructure and financial dealings, 

 (Cambridge, MA) Dataflow Manager to use as its central interface to track and manage clinical information for a current Phase II trial.

 (Research Triangle Park, NC) as number 80 on its "Training Top 125" 2009 ranking.

Of five awards presented at the Invest Northern Ireland Innovation & Export Awards, 

 (Craigavon, Ireland) was awarded the "Exporter of the Year" award, which recognizes the company for its export achievement and growth as a local business that has been exporting for over four years.

 (Kearney, NE) wins a gold award in the "Public Service Interactive" category and a silver award in the "Elements of Advertising Logo" category at the 16th Annual Nebraska ADDY Awards.

 (El Segundo, CA) will be provided with a strategic marketing plan, brand development, and a Web community for patients, investigators, and pharmaceutical development companies.

A new personalized global e-commerce solution, CogenicsOnline, has been created by 

 (Newton, MA) and will be available to its customers, as well as agricultural and academic partners.

Expanding its relationship with Microsoft, 

 (Philadelphia, PA) will now offer an integrated solution of the company's Regulatory Solutions Suite that is built upon and fully integrated with Microsoft Office SharePoint Server 2007.

The Duchenne Muscular Dystrophy (DMD) Charity, 

(London, UK), has made its registry, which allows patients diagnosed with the disease to add themselves to a database for clinical research trials, available to DMD patients in Ireland.

In an effort to move to a paperless environment, 

 (Yardley, PA) has completed its first paperless client audit.

To support sponsors conducting early stage and Phase II trials, 

 (Boston, MA) will now offer Collect, Ready, Hold, a service that allows imaging data to be collected and standardized by a specific protocol and then held in a secured database.

A recent Contractor Performance Report from the NIH gave 

 (Baltimore, MD) three scores of "outstanding," the highest possible, for the company's service, and timeliness of performance and business relations.

 (London, UK) mission to further the expansion of it clinical trial services it has established a new U.S. headquarters, which is based in Cambridge, MA.

With the intention of enhancing its global presence, 

 (Princeton, NJ) has opened three new offices in Kiev, Ukraine; Bratislava, Slovakia; and Tel Aviv, Israel.

 (Saratoga Springs, NY) has expanded its services with its newest global office located in Toronto, Canada.

With plans to retool its Phase I services to meet changing industry dynamics, 

 (Dallas, TX) will be relocating from its current facility based on the campus of the University of Texas Southwestern at St. Paul University Hospital to a larger space, still in Dallas. 

Community

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

Business and People Update April 2009

As the use of biomarkers in clinical trials increases, the decision to use a biomarker in a trial needs to be taken in consideration with the cost and value they bring. Patrice Hugo, PhD, VP Scientific Affairs, Global Central Lab, MDS Pharma Services, told attendees of the recent IIR Central Labs Partnering Conference that the first thing any sponsor should do is clearly define the intended use of the biomarker for its clinical trial. 

"It is so important that it must be the first thing in the RFP," Hugo told

. And it is important to take the time to specify the requirement, he notes, because of the impacts to the information that biomarker use will bring in the clinical trial. To determine these critical and uncritical biomarkers at the outset of the trial is crucial to cost control and experimental drug design. For example, critical biomarkers would be used to determine exclusion/inclusion criteria, or used as a direct measure of drug efficacy being the primary surrogate endpoint. Said Hugo, "In this case, the relationship between the clinical outcome and the biomarker is not necessarily perfect, but is good enough to make a decision. For instance, CD4 count in HIV trials is a well-known surrogate endpoint." An uncritical biomarker, then, is one that is not used to make immediate decisions in the trials. For example, it would bring insight into the disease or the mechanism of the drug. 

Considering the cost and value of biomarkers when deciding to use them in a clinical trial.

Applied Clinical Trials-04-01-2009

Strategic Comparator Sourcing

Path to Self-Employment

eClinical Software: April 2009

CRO Selection & Management

BIO Breeds Hope

Business and People Update April 2009

Costs and Utility in Biomarker Use

Observational Data Under the Microscope

Health IT Offers Both Promise and Problems

Italy Heightens Rules for CROs

Comprehensive Feasibility?

RESCUE Medical Writing

The Rarity Value

EDC Project Success