Whitepapers

Initial IRB Submission: 7 Fundamentals of Success
IRB review and approval are required before a clinical trial can begin. The faster your protocol is approved, the faster you can get to your trial’s starting line. How can you work to get the initial IRB submission… [ Download the Article ]

Critical Questions for Your IRB
Think the IRB review process can’t be easier? Think again. Submitting your protocol to an IRB is the first of many steps in a successful clinical trial. Get it right the first time, and you keep your pace in the drug development race… [ Download the Article ]

Teams Come Together to Initiate a Study in Record Time
With the cooperation of the sponsor, investigator, and IRB, BRANY’s team was
 able to shepherd the entire study start-up in ten business days. Find out more about this engagement and the factors that influenced its success.

Conflict of Interest: Implications for Clinical Research Sites
The final rule is clear about institutions’ responsibilities and accountability for oversight. Even fully staffed research offices may find the new regulations onerous. Learn about key provisions and their implications for organizations.

A Case Study – Preparing for a Successful FDA Audit
BRANY regularly assists clients as they prepare for FDA audits by helping them with labor-intensive tasks such as organizing and labeling information to facilitate the review. Read about our process and get tips for a successful FDA audit.

How a Thorough Reimbursement Analysis Gave a Research Institution Leverage for Better Budgets
To help fill a client’s internal gap in expertise, our team undertook a systematic review of study protocols, including a detailed Medicare Coverage Analysis. See how we were able to leverage the results to increase sponsor budgets.