Clinical Trial Activation That’s in Step With Your Study - Helping You Create a Healthier World
Today, clinical trials are more complex than ever before. You need a trial activation team that has the right expertise to overcome obstacles and keep your study moving forward. By bringing the right mix of people together, we create efficiencies that lead to faster start-up times and streamlined study management.
Your study has many moving parts. Tight timelines, budget restrictions and differing country regulations which further complicate clinical trial management. Our global site activation unit (GSAU) is comprised of specialized teams of highly skilled experts who work in tandem to support your study. These include:
End-to-end site activation management
Site contract and budget management
Essential document collection management
A GSAU lead communicates with you and manages the site activation team to execute all aspects of global and local study start-up. The team works in parallel to ensure your budgets, timelines, documents, regulatory filings and contracts are effectively managed for each site in every country of your study. By synchronizing their efforts, they will navigate the unique complexities of your clinical trial to get every site up and running to meet your study milestones.
Give your study the advantage of having the right team working for you.
Site Activation Management
Anyone Can Overpromise. We Deliver.
Having the right sites ready to go at the right time will give your study the momentum it needs to hit your timeline and recruitment milestones. While achieving the first site activation is relatively easy, our team knows that it’s much more challenging to secure the last site activation on time. Every country and site present their own unique start-up / activation challenges. We create a plan that ensures your study is set up for success, and that there is a clear path and strategy for each country and site; from your first site activation all the way through to your last.
We work with our Study Feasibility Team to leverage data such as indication, site density and site interest/alignment to create an overarching timeline and execution strategy that contains achievable milestones for activating your specific study and country combination within your overall clinical trial timeline.
Our start-up strategy for your study is built to maximize your available subject recruitment months, to set your study up for success and to hit your milestones from start to finish.
Using The Latest Technology To Always Maintain Inspection Ready Documentation
Pharm-Olam's study execution ispowered by the Medidata Rave Clinical CloudTM. Within the Medidata Rave suite of technology, we utilize Medidata Rave® RCM, a cloud-based regulated content management (RCM) tool that allows for the migration, search, access, review and approval of all essential documents. Because we combine this technology with Rave® CTMS for site oversight, you will have access to in-depth study reporting and insights.
This powerful combination eliminates the need to move documents from one platform to another which means you get faster feedback and time added back into your site initiation timeline. To learn more about how Pharm-Olam is powered by Medidata, see our Why Pharm-Olam page.