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Exclusive Life Science Feature reductions in dollars or FTEs) and for multiple stakeholders," he says. This process narrowed the list to 10 projects. The next step involved conducting project-feasibility analyses to determine how much effort each project would require in terms of money, manpower, and expertise. The projects under consideration were also assessed from an intangible perspective (e.g. value to trial participants, higher safety). From that data, TransCelerate built a project road map. "If a project was foundational to the road map — meaning that to complete project 'B' we must first finish project 'A' — it got higher priority than a project that might deliver some immediate value but was not necessarily going to move the overall 'landscape' forward as quickly as we would like," Gill explains. Through this process, the list was narrowed to five projects for initial action: (1) risk-based monitoring, (2) site qualification and training, (3) clinical data standards, (4) comparator drugs, and (5) shared-investigator portal. Each project also included a targeted outcome. For example, the site-qualification-and-training initiative included target outcomes of common criteria for mutual recognition of GCP training and common forms to collect generic information about study sites. Of the initial five projects, TransCelerate has delivered actionable information on all but one — the sharedinvestigator portal. Though Gill is proud of all of TransCelerate's accomplishments, he is most impressed with the success of the comparator-drug initiative. This is because it had the highest degree of skepticism as to its feasibility. "Very few people believed competitive companies would facilitate access to comparator drugs from each other for use in comparator clinical trials," he says. "Once the facts were presented, people realized companies almost always secured comparator drugs; it was just a matter of how painful we wanted to make the process." According to Gill, people began to understand the logical benefits this network would achieve. Companies would be able to launch trials faster. Acquiring drugs would cost less. Most importantly, studies would be safer by avoiding all the issues around drug stability and the possible inadvertent acquisition of counterfeit drugs. On Aug. 6, 2013, TransCelerate announced the successful establishment of the clinical trial comparator network and the initiation of its first transaction. To look at future projects, TransCelerate created the aptly named future initiatives team. Representatives of this team evaluate the current state of clinical trials and postulate what technology, process, or regulatory changes will occur in three to five years. The team then creates a road map detailing how to achieve the clinical trial state of the future. Gill says this strategic process was used to help In the big world of clinical trials, it's the small stuff that counts. WZƐĞƌǀĞƐĂƐĂƚƌƵĞĞdžƚĞŶƐŝŽŶŽĨŽƵƌĐůŝĞŶƚƐ tĞƚĂŝůŽƌĞĂĐŚƉĂƌƚŶĞƌƐŚŝƉƚŽLJŽƵƌƐŝnjĞ ĐƵůƚƵƌĂůďĂĐŬŐƌŽƵŶĚ ƉŝƉĞůŝŶĞ ƐĞƌǀŝĐĞ ĂŶĚŽƉĞƌĂƟŽŶĂůƌĞƋƵŝƌĞŵĞŶƚƐ͘ clearlypra.com >ĞĂƌŶŵŽƌĞ about our ƚĂŝůŽƌĞĚƐŽůƵƟŽŶƐ WŚĂƐĞ/ /s &Ƶůů ^ĞƌǀŝĐĞŝŽƉŚĂƌŵĂĐĞƵƟĐĂůƌƵŐĞǀĞůŽƉŵĞŶƚ ŵďĞĚĚĞĚĂŶĚ&Ƶůů^ĞƌǀŝĐĞ^ŽůƵƟŽŶƐ dƌĂŶƐĨŽƌŵŝŶŐůŝŶŝĐĂůdƌŝĂůƐƚŚƌŽƵŐŚ KƵƌWĞŽƉůĞ /ŶŶŽǀĂƟŽŶ dƌĂŶƐƉĂƌĞŶĐLJ © PRA 2014. All Rights Reserved. 1.14 January 2014 LifeScienceLeader.com 27