The need for sponsors to collaborate with external partners, whether it's legal counsel, CROs, or manufacturers has become a daily occurrence. Documents such as contracts, informed consent, and protocols require authoring, review, and approval from individuals inside and outside the company. This trend will continue, as industry increases outsourcing efforts at the same time the amount of unstructured content generated skyrockets.

There are many different use cases in the clinical trial process that require this type of data exchange. For example, Investigator's Brochures are exchanged between sponsors, investigators, and Institutional Review Boards (IRBs). These are not static documents, thus requiring collaboration as updates are needed. Creating, reviewing, and approving informed consent language requires a collaborative process that involves input from investigators and IRBs.     

Failure to have a reliable, consistent, and compliant approach to document exchange and collaboration with relevant parties can result in unnecessary delays and additional costs. 

Many CROs and sponsors collaborate and exchange content either through email, fax, File Transfer Protocol (FTP) or hosted third-party solutions. Each method has disadvantages in terms of security, document versioning, cost, efficiencies, and information loss. 

For example, email may be easy to use, and is by far the most widely used communication mechanism, however, sending attachments this way is typically not secure because most of us aren't encrypting attachments. Attachments also cause our mailboxes to quickly exceed their quota. More troublesome is that there is often confusion about which version of the attachment is the latest. The end result is a time-consuming, frustrating, and error-prone process of manually merging multiple documents to ensure the latest edits are incorporated into a single document. 

Like email, facsimile technologies are commonplace in the workplace. Most fax solutions today convert incoming faxes to digital format and email the document to the recipient. This may be sufficient if the receiver does not need to modify the document. However, in a collaborative environment where both the sender and receiver must author or edit the document, the resulting PDF or TIFF is not an editable document and is unsuitable for this purpose. 

FTP collaboration, while not as commonly used as email or fax, has a long history of providing a secure means of exchanging files. However, these solutions require more advanced technical knowledge, are cumbersome, and typically require IT involvement to set up and configure permissions. Security aside, the lack of version management is as much a problem with FTP as it is with email. 

Some hosted third-party ("on-demand") solutions solve some of the problems of email and fax by providing a common repository for all parties so there should be no question about which version of the document is the latest. Features such as document version control are useful in that you can go back to an old version of a document and have greater insight into how it changed throughout the collaborative process. However, not all on-demand solutions offer versioning features, including one of the leading solutions. Some on-demand solutions do provide audit capabilities. This provides for better compliancy by tracking the user, date, and time for each document change. 

On-demand solutions have a potentially large cost downside, however. These services typically charge by the number of documents or the amount of storage space consumed. As such, they can quickly become expensive. In addition, these solutions require a username and password to connect, which is typically not synchronized with the user's network username and password. This requires users to remember yet another username and password. 

The drawbacks associated with all of these methods, some quite serious, has escalated the need to find a more secure, cost-effective, and user-friendly way to manage documents. 

Another solution is peer-to-peer data sharing, which is an approach to computer networking where all computers share equivalent responsibility for processing data. Peer-to-peer networking (also known simply as peer networking) differs from client-server networking, where certain devices have responsibility for "serving" the data and other devices consume or otherwise act as "clients" of those servers. 

In a peer networking solution, desktop computers can be configured to allow sharing of files, printers, and other resources across all connected devices, allowing data to be shared easily in both directions—whether downloads to or uploads from your computer. Peer networking can also handle a very high volume of file sharing traffic because the load is distributed across many computers.

Because trial-related documents contain proprietary information and sensitive data, improved security is a must. For example, if a CRO is working with three separate sponsors, it is important, from both a compliance and contractual standpoint, to have three separate workspaces to reduce the risk that a confidential document from sponsor A is not seen by sponsor B. Peer networking documents that are exchanged between any two parties are stored within their own individual workspace. 

An effective peer network also automatically encrypts and replicates data among users, allowing every user to have constant access to the latest shared documents—even if they are not online. It is also important for the solution to encompass built-in disaster recovery by having the data stored in at least two separate locations. 

Peer networking should allow CROs to track and manage documents in several ways, including version control and status change notifications via email or text. Additionally, automatic status update indicators should be displayed to alert users of new updates within the application. 

One of the most important benefits of a peer networking solution is the elimination of the storage and file-transfer costs typically associated with on-demand services. The ideal peer networking solution requires minimal end-user training and greatly reduces administration, resources, and maintenance from a central IT infrastructure, lowering overall costs and accelerating the investment payback. 

An exchange and collaboration solution should allow for integration with an existing document management system. For example, take the scenario where an Investigator's Brochure is initially created. The authoring and review should happen in a collaborative workspace but, once complete, it should be moved seamlessly into a document management system such as Documentum or SharePoint, where it can go through a formal approval process with electronic signatures. When the brochure needs to be modified at a later date, a change request should be submitted, and once approved, the brochure should seamlessly be copied back into the collaborative workspace. Then it can be modified by all relevant parties. After the brochure is revised, it should be moved or published back into the document management system. 

A good peer networking solution will allow sponsors and CROs to balance multiple factors such as cost of ownership, ease of use, robust version control capabilities, auditing, and integration into a true document management system. The end result: a secure and comprehensive solution with improved workflow, 21 CFR Part 11 compliant eSignatures, change management, and records retention capabilities. 

1. J. Malek, Transforming Life Sciences: The Connected Life Sciences Company, Cisco Internet Business Solutions Group (IBSG), July 2009. 

Peer-to-Peer, Harnessing the Power of Disruptive Technologies

 (O'Reilly Media, Sebastopol, CA, 2001). 

 is President and Cofounder of Sitrof Technologies, 700 Alexander Park, Princeton, NJ 08540, email: 

Articles

Partnerships in Clinical Trials

The benefits of peer-to-peer networking over email, fax, FTP, and hosted solutions.

Rethinking Document Sharing

The global community is rallying to stop the increase of Clostridium difficile, a bacteria that spreads throughout the intestinal system causing diarrhea, fever, nausea, pain, and/or serious conditions such as colitis, which can result in death. 

C. difficile is an anaerobic spore-forming bacterium, present asymptomatically in approximately 60% of infants but only about 3% of healthy adults. It belongs to the Clostridium family of bacteria, which also includes C. tetani (tetanus) and C. botulinum (botulism). When the natural microbial flora of the gut is disturbed, usually as a result of antibiotics, and a patient ingests C. difficile spores, the bacteria can multiply and release the two toxins, which cause gastrointestinal pathologies in humans known collectively as CDI. 

It is easy to contract C. difficile, and several studies show that it is a growing cause of illness especially in hospital patients. C. difficile is now among the most common causes of hospital-acquired infection in Europe and North America. In an effort to prevent the bacteria's propagation in the UK, the National Health Service has instituted a mandatory C. difficile reporting program. Last year, more than 35,000 cases of C. difficile were detected in British NHS hospitals and the bacteria were noted on the death certificates of 438 nursing home residents. 

To add urgency to the need for a vaccine, researchers have identified a more virulent, antibiotic-resistant strain that spreads easily and causes greater morbidity and mortality. 

Treatment of C. difficile infection includes the use of one of two antibiotics. Nonantibiotic approaches for managing C. difficile infection are badly needed, since the alteration of the gut flora associated with antibiotics triggers the infection in the first place. There is also considerable concern about the emergence of antibiotic-resistance in C. difficile and other bacteria. Vaccination has the potential to be a very effective strategy to combat gastrointestinal pathologies caused by C. difficile, along with improved antibiotic stewardship and infection control practices. 

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, has a long history of developing vaccines to address significant, unmet medical needs and substantially improve current care standards. Sanofi Pasteur provided more than 1.6 billion doses of vaccine in 2008, making it possible to immunize more than 500 million people across the globe. 

A Phase II clinical study of Sanofi Pasteur's C. difficile vaccine is currently ongoing in the UK and will soon expand to the United States. While the target indication for the vaccine is primary prevention of CDI, this trial in infected patients aims at providing proof of concept of the vaccine approach in patients with existing CDI, who are at risk for recurrent CDI disease symptoms. 

Vicki Tyler, Clinical Trial Manager at Sanofi Pasteur's Massachusetts facility, oversees the study. She explained, "We have been conducting C. difficile research for quite some time. There is a huge unmet medical need throughout the developed world. While new therapeutic agents are being developed by others to treat identified cases, the field has begun to recognize that prevention is the preferred strategy and there is no better approach to prevention than vaccination." 

The Phase IIb trial involves more than 600 participants with acute CDI at about 30 centers in the UK and 45 in the United States, and began in the fall of 2009. Participants will be randomized to four study groups. Three groups will receive the vaccine, while the fourth will be given a placebo. All subjects will receive standard of care antibiotics. 

Sanofi Pasteur's candidate vaccine uses a toxoid-based approach, which has been used extensively in the licensed vaccines against tetanus, diphtheria, and pertussis (whooping cough). This candidate vaccine has successfully completed Phase I clinical trials in more than 200 participants to evaluate its safety and immunogenicity. 

Sanofi Pasteur had used electronic patient reported outcome (ePRO) solutions provider PHT Corporation in previous trials. "eDiaries motivate subjects to complete their daily questionnaires. In addition, it is much more efficacious to ask subjects how they feel at a precise moment and get an immediate, accurate answer," said Tyler.  

PHT's eDiary, the LogPad, associates a time and date with every entry, ensuring researchers know exactly when subjects completed their reports. With paper diaries, researchers can only assume people remember to actually record time while completing the diary and that the information is accurate. 

Moving to ePRO in Phase II was also advantageous because Sanofi Pasteur wanted to conduct long-term follow up and hoped the eDiaries would, in addition to fostering a solid relationship between investigators and subjects, be helpful further along when they became patients again. "Sites have a daily electronic connection with subjects," Tyler said. "Because the LogPad gives subjects an important connection to the study, we are more likely to keep them engaged all the way to the end of the trial and beyond." 

For Phase I, Sanofi Pasteur tested healthy volunteers rather than subjects with C. difficile. These initial studies evaluated various dose levels to determine how volunteers would respond. The Phase II trial seeks to evaluate various dose levels in infected patients. In designing the Phase II trial, Sanofi Pasteur started with the Phase I questionnaire in order to analyze the data from both the Phase I and Phase II studies in combination. Sanofi Pasteur also included standard quality-of-life questions in the Phase II study, which are included on the LogPad. 

The company's years of experience developing questionnaires related to vaccine studies allowed Sanofi Pasteur to work with PHT to create an easy, yet comprehensive, set of questions for the eDiary. Because Sanofi Pasteur was focusing on the elderly population in this study, they designed a thorough questionnaire with simple, multiple-choice questions to reduce burden. As a specific adaptation for this population, PHT provides a larger stylus.  

Sanofi Pasteur collects a baseline before each subject receives the initial vaccination in the hospital. During the baseline period, subjects receive training on how to use the LogPad and use it daily to become accustomed to the device. On the evening of each injection day—at zero, seven, and 28 days—subjects complete a questionnaire that asks about nausea, stool, and bowel movements, as well as questions about the injection site and basic questions about their well-being. Then the subjects answer daily diary questions at home for seven days after the injection. 

To ensure that all entries are confidential and secure, study participants sign their LogPads with a private access code. Questions appear on the screen according to how they respond to each previous question. If a subject responds that he or she has abdominal pain, a follow-up question about abdominal pain comes up on the LogPad. 

In training, subjects are asked to answer every question; the lack of a response automatically triggers an alert to their site to follow-up with the subject. Additionally, if subjects do not record data in their LogPads, sites may contact them to ensure they are not experiencing any issues with the LogPad or the trial. Site personnel along with CRO and Sanofi Pasteur project team members have secure, real-time access to real-time patient compliance data throughout the study via PHT's online data viewing portal, StudyWorks.  

Tyler said there are several significant benefits of using an eDiary over paper, for both sponsors and subjects. When a trial uses paper diaries, investigators expect that subjects will end up entering information when they're sitting in their cars before their scheduled visit. Now, investigators know they are receiving real-time information and that diary data is recorded at the times specified by the protocol. As an added trigger, the LogPads have an alarm feature that investigators set to remind subjects to complete their questionnaire every day. 

To select the most appropriate eDiary system, Sanofi Pasteur vetted four vendors for this study. They cited the size of the screen, ease of use, and professional support as key factors in their decision to choose PHT LogPad. 

Sanofi Pasteur expects to achieve specific improvements in the data gathering processes, data quality, patient compliance, and trial process efficiency by using eDiaries for Phase II. "Phase II study subjects are more conscientious about completing questionnaires," Tyler commented. "They enjoy using the electronic device and were delighted to learn how easy the LogPads are to use."  

 is Vice President of Marketing and Product Management at PHT Corporation, 500 Rutherford Avenue, Boston MA 02129, email: 

: Pharmaceutical company, vaccines division of sanofi-aventis Group 

: Vicki Tyler, Clinical Trial Manager at Sanofi Pasteur 

: Improve data gathering, data quality, subject compliance, and trial process efficiency 

: eDiaries; LogPad from PHT Corporation    				

Sanofi Pasteur collects quality of life and safety data with eDiaries.

ePRO in Action for Phase II

The success of clinical trials is directly related to finding good quality volunteers and patients, which can be extremely challenging. Traditional methods of clinical trial recruitment, such as physician referral or paper-based methods have a very low success rate. One popular method of recruitment is advertising, used in a wide range of environments such as universities, hospitals, clinics, and in the media. During the recruitment process traditional methods can be helpful; however, they all require the subject to take the first step. Ultimately, many good quality volunteers simply never find out about clinical trial opportunities. 

Text messaging technology is already widely used in consumer markets with immense success and is now developing into a workable solution for use in the pharmaceutical industry, particularly within clinical trials. With more than four billion mobile phone users estimated worldwide, this technology is a well-known means of communication. It can be successfully applied in the pharmaceutical and health care industries as a form of direct communication with clinical trial subjects. 

This article will provide an in-depth look at a typical application of text messaging technology for patient recruitment at MDS Pharma Services. 

MDS Pharma Services provides drug discovery and development solutions for the pharmaceutical industry. With more than 3000 employees globally, MDS Pharma Services applies advanced scientific and technological expertise from lead optimization, pre-IND research, early clinical research, and bioanalysis through to global clinical development, central lab, and centralized cardiac services. 

MDS Pharma Services has study locations worldwide, including an early stage development clinic in Belfast, UK. The Belfast clinic carries out a wide range of studies, including Phase I studies testing new drugs in healthy human subjects. As a CRO, MDS has recruitment targets to meet, often on a short deadline, and must find and dose participants as quickly as possible. In 2006, its Belfast clinic began to experience challenges with its existing methods of subject recruitment and communication. As a result, the CRO looked to Exco InTouch to improve these areas through implementing mobile phone technology.  

Typically for Phase I studies, MDS Pharma Services requires an average of 30 dosed participants per study. However, to achieve this target, 300 potential participants are often initially contacted. Traditionally, it used a proprietary database to find potentially appropriate participants and then sent letters to each one and awaited a response. As the company's target population is largely composed of university students and other young people, MDS Pharma Services found that the potential participants' postal addresses often changed, making successful contact by mail difficult. In addition, it found awaiting a response from a potential participant to be a lengthy process, so it began to investigate alternative forms of participant recruitment and communication. MDS Pharma Services initially approached Exco InTouch for an alternative mobile phone-based solution based on the company's reputation for delivering effective patient communication solutions. 

In clinical trials, text messaging technology can be utilized to recruit, locate, and screen potential patients. Response rates in clinical trials can range between 5% to 10% when traditional methods of patient recruitment, such as letters, are deployed. Text message technology can see rates of more than 30%. When compared with traditional methods, where results may not be seen for weeks or even months, text message-based recruitment results are immediate. 

Cell phone technology can complement traditional advertising and patients can register for a trial by sending a text message to a short code, for example "Text TRIAL to 85342 to receive more details." Once the text is received, multiple workflows can be activated. These include a short text message-based questionnaire about the age, sex, and condition of the patient or a response can be sent that directs the patient to the nearest recruiting center to be screened for suitability. 

The CRO initially approached Exco InTouch to manage a number of recruitment campaigns. These preliminary campaigns involved sending simple text messages to MDS Pharma Services' database of potential participants. Initial outreach was focused on a study requiring up to 1700 potential participants, and during this study, response rates increased by 32%. 

MDS Pharma Services then implemented two strategies: First, the initial outreach was staggered to include up to 400 potential participants at one time, enabling the response system to manage responses from interested volunteers. Secondly, a two-way recruitment strategy was developed to allow participants to demonstrate interest via text message rather than telephoning the call center. This enables the CRO to analyze the profiles of interested participants and easily measure response rates against study targets and deadlines. 

"The services provided by Exco InTouch are critical in ensuring that participant enrollment is on time and within budget. Using mobile phone-based technology for participant recruitment enables us to find suitable study participants more quickly than with any other method," said John Taylor, Head of Patient Recruitment at MDS Pharma Services. 

In addition to the patient recruitment strategies, MDS Pharma Services has also implemented compliance-based technology from Exco InTouch, which enables the CRO to send timed medication and visit reminders, reducing lost-to-follow-up. If participants no longer want to take part in the study, they can easily text "NO" when receiving communication from MDS Pharma Services, reducing the time that it spends on soliciting responses and ultimately improving the quality of trial results. 

The cell phone technology provided by Exco InTouch is fully compliant with both the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the EU Directive 2002/58/EC (Directive on privacy and electronic communication). This ensures that all data are encrypted to 256 bits, patient consent is obtained before communication begins, and that there is a simple opt-out service for patients or sites. Additionally, the solution has full message tracking capabilities and generates delivery reports to guarantee the surety of receiving the messages, providing a full audit trail in line with these regulations. Exco InTouch computer systems are also fully validated to comply with FDA 21 CFR part 11 guidelines. 

Using outreach via mobile phone, MDS Pharma Services has seen typical response rates of 50% to 60% compared to approximately 5% when using paper-based methods. Through using the technology for subject recruitment, MDS Pharma Services can also address issues that arise during the trial. For example, during a recent study, it found that all suitable participants failed the blood test stage during screening. In order to keep to the deadline, the company needed to find 50 new suitable participants instantly, a feat not possible using paper-based methods or even email. However, by sending out a mass communication via text message, MDS Pharma Services was able to quickly find new participants in order to meet the study deadline.  

Implementing cell phone communication strategies alongside existing procedures or as a standalone method ensure that CROs such as MDS Pharma Services can benefit from significantly improved overall data quality. This can lead to more successful clinical trials with improved recruitment rates and reduced lost-to-follow-up. Using text messaging technology in clinical trials offers a cost-effective, powerful, and nonintrusive method of direct-to-subject communication and overcomes the most common challenges in clinical trials. The technology is easy to use for both trial organizers and candidates and can help identify and locate potential candidates and encourage patients to proactively contact sponsors and CROs. 

 is Chief Executive Officer of Exco InTouch, email: 

 is Associate Director, Patient Trial Services, for MDS Pharma Services.

: John Taylor, Associate Director, Patient Trial Services, MDS Pharma Services 

 Letters to potential subjects in proprietary database 

 Exco InTouch Text Messaging Technology      			

The use of text messaging technology for recruitment in Phase I studies.

Trial Outreach via Texts

Biopharmaceutical and medical device companies have made EDC (electronic data capture) a cornerstone of clinical trial and registry management because of its proven, significant process improvements over paper-based systems. 

EDC is a technology that allows sponsors to conduct clinical trials and registries electronically, instead of using outmoded paper processes. EDC has shown tangible efficiency gains in data capture across the board, including dramatic efficiencies in large trials with many patients, locations, and data points. EDC simplifies and accelerates the clinical trial data collection, cleaning, and management process by organizing and storing data in a secure, central database. 

A Clinical Endpoint Committee (CEC) is a panel of unbiased, third-party experts charged with centrally reviewing and classifying suspected endpoints, ascertaining whether they meet protocol definitions, and providing standardized endpoint outcomes for the purposes of statistical analysis. CECs review and adjudicate endpoint-specific data, applying complex medical definitions to determine these outcomes. 

Information reviewed by the CEC for each endpoint is primarily based on source documentation from the patient chart, including documents such as: Admission History & Physical, Discharge Summary, progress notes, medication administration records, procedure reports, lab reports, radiology reports, consultation notes, medical imaging data (e.g., chest x-rays, angiograms, echocardiograms, ultrasounds, MRIs), data from external devices (e.g., pacemakers), and autopsy reports. 

It is through review of this kind of descriptive chart documentation that CEC adjudicators are able to independently and critically assess the circumstances surrounding the suspected endpoint, so that they can produce a medically precise adjudicated outcome. 

The use of CECs to adjudicate suspected endpoints has increased considerably over the past 10 years. CEC-adjudicated endpoint outcomes can figure prominently in a number of key clinical trial decision-making processes: power calculations, periodic safety reviews by Data Safety Monitoring Boards, sample-size reestimation and other interim analyses, next stage progress for adaptive design trials, study completion for event-driven trials, and overall results for efficacy and safety analyses. 

Implementation of a CEC requires cross-functional planning with respect to study timelines, budget, and quality management; a well-defined integrated data capture strategy for effective endpoint case management; and a CEC adjudication process that is structured to deliver consistent, reliable, and accurate results. 

With the increasing focus on proactive management of product benefit–risk balance and the prominence with which endpoint data factor into this equation, it is imperative to minimize any impact of process-driven variability on endpoint outcomes. The process controls and data integrations offered by online Endpoint Adjudication System (EAS) technology contribute to meeting this objective by enabling project teams to achieve new levels of standardization and consistency, by enhancing the timeliness and quality of endpoint data capture, and by facilitating more rapid and robust decision-making. 

Online endpoint management & adjudication

One of the most important clinical trial capabilities made possible by EDC is online adjudication to support the CEC endpoint adjudication process. Until recently, online adjudication was often omitted from the EDC workflow because it required features and performance that were not available in existing platforms. But now it is a vital component of EDC, successfully implemented in tens of thousands of cases in trials across a range of indications. 

Use of online EAS technology enables implementation of an end-to-end, transparent endpoint workflow, which creates significant cost efficiencies and measurably reduces cycle times by offering a collaborative workspace for all relevant stakeholders to contribute to the endpoint process, by partially automating the process steps with a flexible electronic workflow, and by integrating all components of the endpoint management and adjudication workflows into a single, seamless system, which is imbedded within an EDC platform. 

A major benefit of performing all related endpoint process steps within an EDC platform that includes an online EAS, is that each essential process component is linked into an overall integrated system process map. This eliminates manual handoffs, reduces reconciliations, and facilitates paperless document collection, data integrations, and real-time information exchange. The process components of an integrated EDC endpoint workflow begin with eCRF endpoint reporting, and move through electronic source document and medical image collection, case review and processing, translation of non-English source documents, electronic dossier compilation, and paperless submission of endpoint dossiers to CEC adjudicators. CEC adjudicators then conduct an online dossier review and provide their adjudicated outcomes via eCRF (see Figure 1). 

Endpoint workflows are dynamic and interactive, with multiple steps and dataflows, contributors and stakeholders.  As a result, project teams, endpoint data coordinating centers, and CECs need endpoint data and documents to be centrally accessible in a collaborative workspace, where data and document exchange activities are optimized. 

Online EAS technology provides an integrated environment with role-based activities across multiple parties and a cohesive workflow that can be configured to drive both standard and custom models for endpoint data collection and information exchange. 

Online EAS technology also creates a collaborative workflow that includes sites, the clinical project team, safety and medical personnel, the endpoint data coordinating center, the translation vendor, adjudicators, data and project managers, and biostatisticians. Stakeholders can access the system to perform data review, complete role-based actions, and review standard, customized, and user-empowered status reports (see Figure 2). 

Since final adjudicated outcomes must be available rapidly for a number of key decision-making purposes, the endpoint adjudication process is always on the critical path. Online EAS technology can achieve significant reductions in overall endpoint cycle times, shortening the time from endpoint report to final adjudication by a third of the total duration typically observed with a paper-based process (see Table 1). Use of online EAS technology also brings a number of logistical and financial benefits to projects and programs with endpoint management. From a labor standpoint, this approach eliminates paper from the workflow, removes a number of paper-based steps, partially automates a number of remaining steps, and reduces the volume of data and statuses that need to be tracked manually. This approach also lowers project costs by eliminating courier and fax charges, which have traditionally been required to transport paper documents from sites to endpoint coordinating centers to CEC adjudicators. In addition, this approach reduces, and in some cases eliminates, travel costs, which have traditionally been required for regular face-to-face CEC adjudication meetings. 

Incorporating all endpoint-related data capture and workflows into an EDC-based platform makes the endpoint reporting, endpoint management, and CEC adjudication processes fast, convenient, cohesive, and cost-efficient, with a consistent and high-quality result. 

Investigators appreciate the user friendliness of the Endpoint Reporting eCRF format, which is a feature of online EAS technology. The system allows sites to use the same eCRF page to complete data fields and attach supporting source document files for suspected endpoints.  The design of the eCRF also guides users through a logic tree, so that it is easy for the site to determine what is needed for each type of suspected endpoint that has been identified. 

Online EAS technology extends the advantages of EDC for clinical data collection. For example, the system can collect eCRF data and store source documents in any file format. This includes advanced functionality for collection, storage, and annotation of even the most complex documents—medical image data. As a result, online EAS technology streamlines and speeds the endpoint data coordination workflow. 

Online EAS technology provides flexible, easily configurable workflow options to support all of the different CEC adjudication models that are in use. There are options for batched endpoint submissions, as well as real-time case-by-case submissions. In addition, it is not necessary for CEC adjudicators to log in to check whether there are cases or queries to address, because the system notifies them via an email alert if they have a new action to take. And these alerts can be grouped at any frequency to prevent item-by-item notifications. 

Online EAS technology offers full-scale technical infrastructure support, including a 24x7 Help Desk to support system users, on-demand video training, and on-screen CRF completion guidelines to assist all system users with data capture. The system also includes a project library, including: online posting of system user manuals, trial protocols, CEC charters, and endpoint definitions. 

While online EAS technology is configured as a component of a specific EDC platform and is ideally suited for implementation end-to-end within a single environment, the technology can be used as a standalone system, and it can successfully interface in a modular fashion through integration with other EDC platforms as well—as long as proper measures are put in place to control for the impacts of a multiple system environment on stakeholders such as sites, monitors, and data managers (e.g., through clearly delineating the data capture purpose within each system and automating data exchange between systems to minimize or eliminate data reconciliations). This versatility enables the benefits offered by online EAS technology to be realized across a wide number of settings. 

The advent of EDC-based, integrated online EAS technology, as a complete approach to clinical asset management, delivers quantifiable improvements and value across virtually every aspect of the endpoint process and fully incorporates it into the overall clinical trial process.  The distinct advantages of this approach begin with ease of use and flexibility. Significant gains are achieved from shorter cycle times and notable project cost savings. In addition, there is a marked increase in quality by enabling comprehensive review of all necessary documentation for adjudication, by enabling early detection and resolution of discrepancies, and by contributing significantly to overall process standardization and compliance. The result is a thorough, well-governed process that operates in real-time, achieving rapid delivery of robust adjudicated endpoint outcomes for critical project-level and product-level decision-making. 

Considering the extensive benefits it has to offer, it's clear that online EAS technology is an excellent response to the new clinical, regulatory, and business challenges faced by the biopharmaceutical and medical device industries. 

, MA, MFA, ABD, is Senior Director & Global Unit Head, Clinical Safety & Endpoint Management Solutions, Lifecycle Safety, for Quintiles, Inc. 

* is Senior Director, Global Sales & Strategic Partnerships, at KIKA Clinical Solutions, email: 

. Cathy and Zaher have been working in collaboration for the past three years to bring joint value to the successful set up and delivery of endpoint adjudication programs through alignment of expertise in endpoint management operations with innovation in clinical system solutions. The resulting online EAS platform has been presented to major biotechnology and pharmaceutical companies that have embraced the value, and utilization is rapidly gaining momentum.

*To whom all correspondence should be addressed.

How an integrated, EDC-based system can optimize the endpoint process.

Supplements-03-01-2010

Rethinking Document Sharing

ePRO in Action for Phase II

Trial Outreach via Texts

Electronic Endpoint Adjudication