Clinical Study Management


clinical-affairs-outsourcingCHALLENGE:

A small medical device start-up required support planning, managing, and executing a post-market clinical study for their Endoluminal Occlusion System (EOS™) devices. The sponsor required an immediate plan to transition the ongoing study to AlvaMed and to open up a new treatment arm for the study. A project plan and tracking tools needed to be developed and new sites needed initiating and legacy sites needed closure. The company did not have existing staff that could support a clinical trial and needed additional resources. AlvaMed was asked to provide those resources due to their in-depth knowledge and experience managing and executing clinical studies.


APPROACH:

AlvaMed provided a network of in-house and networked resources to plan, design, execute and manage the study. AlvaMed created and maintained study documents, the clinical trial master file, the EDC, and other applicable files. AlvaMed performed duties of a clinical research organization – site evaluation, monitoring, correspondence between sponsor/site/ethics committees, data management, and oversight. Reports and study updates were provided to the sponsor in a timely manner.


RESULTS:

AlvaMed effectively conducted the post-market study and is in the close-out process after meeting the client’s enrollment needs.

During the project AlvaMed created, performed, and/or maintained:

1) The study’s Clinical Trial Master File and associated clinical procedures/documents

2) Reports and clinical tracking worksheets.

3) Site initiation, clinical monitoring, site closure.

4) Communication with applicable regulatory bodies.

5) Data management (EDC).

6) Clinical project management.