The Clinical Trial Diary

EDC Platform Investment Is Critical To A CRO’s Survival

Posted: 10/11/2016

As the costs and complexities of running clinical trials increase, so does the impetus, indeed obligation, to invest in fully integrated eSystems that are essential to simplifying the overall clinical trial process. Electronic Data Collection (EDC) platforms that are used in the clinical trial arena are numerous and many offer similar variations on a theme. For a variety of reasons, sponsors tend to have a preference for the use of a particular EDC platform, and as such, contract research organisations (CROs) must be reactive and nimble in their ability to use a variety of EDC systems. Inevitably, there is a continuous need for CRO’s to invest in their EDC knowledge and capabilities in order to remain flexible and therefore competitive in the current environment.

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“Increasingly there is an obligation for CROs to invest in a diversity of EDC capabilities,” Paul Donnelly, Associate Director, Data Management and Project Systems at George Clinical, a leading CRO in Asia said. “George Clinical’s data management and project systems team are regularly called upon to engage in an extensive range of trials across a variety of therapeutic areas and study design – ranging from the Phase I trials rights through the phases and into the investigator initiated studies, registries and also epidemiology studies. Additionally, George Clinical have an extensive therapeutic breadth, including cardiovascular, oncology and medical device projects for a variety of sponsors, including mid- to large-sized pharma, bio-tech companies and non-profit research institutes. It is this diversity of projects that drives our need to have a number of EDC solutions that gives us the capacity to respond to the needs of our client with a tailored approach that best suits our sponsors systems preference and trial protocol, regardless of complexity.”

Investment in EDC platforms is critical to the future viability of a CRO. Continuous training and resourcing enables CROs to deliver relevant advice and service in a timely fashion to all stakeholders. This is of critical importance in the high-cost world of clinical trials. Another critical value-add to global sponsors is the ability to have strategically positioned EDC resources in key geographic hubs. This allows EDC resources to respond quickly to sponsors when required. Again, immediate assistance to all stakeholders is of the utmost importance to ensure seamless interaction and communication is maintained to address any issues throughout the conduct of a trial, from design through to final delivery. Ongoing overview and reporting of data provides the sponsor, sites and operational teams with the feedback on the quality and integrity of the data being collected, ensuring quality.

“George Clinical is a global organisation, with particular expertise running clinical trials in Asia,” Mr Donnelly explains. “As such we focus our EDC resources in key areas throughout the region, with our main operational hub being our head office in Sydney, Australia, and key offices in Beijing and Bangalore also, where we tend to have a large number of project sites. This allows us a great deal of engagement at a local level within the project and greatly assists in the data collection process.”

A variety of platforms provide enhanced opportunities to tailor data management solutions to fit study requirements and sponsor specifications. George Clinical, for example, has a number of preferred EDC platforms namely: Merge eClinicalOS, Medidata’s RAVE and Medrio. This diversity of options offer a certain level of dexterity when select an EDC solution to best meet the requirements of a protocol and a sponsor.

Without spending too much time dwelling on the specifications of the main players in this space, George Clinical have provided an example of how they use each of their EDC platforms.

Merge eClinicalOS (eCOS) -

eCOS is a fully integrated EDC system that provides an easy-to-build system with competitive data point fees and minimal infrastructure requirements.

“This EDC system not only provides us with time and cost efficiencies, but also provides additional functionality within the database system, which are of great importance for many of our projects. For instance, the drug dispensing and endpoint adjudication modules have been of significant benefit for many of our trials. We are able to perform these additional activities within this EDC. Otherwise we would require a separate solution to be used with any integrations with the EDC set-up as required. George Clinical’s data management team first used this software to take advantage of the endpoint adjudication function, but soon expanded use as a full EDC solution.”

Medidata RAVE –

Medidata RAVE is the largest player in the area of EDC systems and is the preferred EDC solution of many of the large pharma and biotech companies.

“Medidata RAVE is the newest member of our suite of EDC systems. After many months of training, GC data management team have now achieved accreditation as a RAVE provider. We are now able to offer this solution to our customers. Already, George Clinical have engaged with a major pharma sponsor to develop and implement a RAVE database for their trial, which we successfully deployed ahead of schedule.”

Medrio -

Medrio is a fully integrated EDC platform that provides a simple, easy-to-build system with competitive data-point fees and minimal infrastructure requirements.

“This is George Clinical’s EDC system that offers time and cost efficiencies when compared to some of the larger solutions available. Our data management team have used Medrio for a number of years and have recently used it to great success in early phase trials for international sponsors.”

In closing, a CROs investment in EDC systems is one of its most significant strategic investments. In today’s clinical trial environment, where costs and complexities continue to rise, the ability to access an EDC that is tailored to the needs of a study and run by locally based experts is of the utmost importance.

Posted: 10/11/2016


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