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LIFESCIENCELEADER.COM 43 JULY 2014 pieces of the TMF into a coherent pack- age. During the past decade, sponsors have been attempting to improve overall trial efficiency by concentrating opera- tional efforts on fewer but more strategic CRO partners. In fact, 65 percent of spon- sors are now using fewer than five CROs, according to Vantage Partners' Sponsor- CRO Collaborative Study. CenterWatch research from 2013 shows that 87 percent of the top 30 pharmaceutical companies have at least one strategic functional ser- vice provider (FSP) or multi-FSP alliance — collaboration that will clearly play a pivotal role in their success or failure. With fewer partners, it is easier to speci- fy which one is responsible for which ele- ments of the information and which SOPs will be used. When partners run multiple trials together, both benefit from using a single process to manage their collabora- tion. A shared system for collaboration results in efficiencies in trial execution, which once defined, can be reused from study to study. In many cases today, however, the sponsor and/or CRO maintain an eTMF on their own network, blocking access to outsiders. In this scenario, stakeholders send documents via paper shipments or email and maintain separate copies of TMF documents that need to be reconciled at the conclusion of the trial. Alternately, a cloud-based eTMF is by its very nature easily and securely acces- sible by all parties. Sponsors can define new processes that are more efficient up front, maintain visibility throughout the trial, and help ensure the TMF remains inspection- ready at all times. This type of collabora- tive and open process begins by uploading a document into a cloud eTMF. Because all parties have direct access, physical dis- tribution of content becomes obsolete, eliminating the need for emailing copies of documents as attachments. Renee Fate, senior manager of document management at Kythera Biopharmaceuticals, describes one process the company is redefining in an initiative to take full advantage of its new cloud TMF system. "We partnered with a CRO for both regulatory and clinical sup- port, and their SOPs had both teams send- ing us the same document. Next time, we'll define one process that has their clinical Learn more about Tria OA solutions at CRFHEALTH.COM With Tria OA solutions, it's never been faster or easier to collect Clinical Outcome Assessments. team uploading documents into our cloud TMF where I can review them before send- ing the approved documents to both of our regulatory teams." Managing collaborative processes within the eTMF combines information exchange and tracking into a single system. Not only does collecting TMF documents become more efficient, but also all parties gain visibility into status and outstanding tasks. "We are shaving at least 40 percent off the amount of time needed to reconcile the TMF at the conclusion of a trial with our cloud system," added Fate. "Now, we 0 7 1 4 _ C l i n i c a l T r i a l . i n d d 2 0714_ClinicalTrial.indd 2 6 / 2 0 / 2 0 1 4 1 2 : 2 9 : 5 3 P M 6/20/2014 12:29:53 PM