Regulatory and Financial Document Creation, Collection, Review, and Maintenance

Timely collection of accurate regulatory and financial documentation throughout the life of your clinical trial is vital to meeting study timelines. BMA will work with your clinical sites at study start-up and throughout the duration of the trial to collect, review, and maintain all required documentation.

One of the first critical steps of the clinical trials process is ensuring that sites are ready for initiation and enrollment as soon as possible. We work with site personnel to collect informed consents, IRB/IEC approvals, CVs, study agreements, financial documents, laboratory documents, site training, and other study related materials to meet your timelines for study initiation.

Throughout the clinical trial, we will manage, collect, and track all ongoing documentation, such as revisions to study or protocol agreements, annual/semi-annual IRB/IEC renewals, laboratory documentation, revisions to informed consents, and safety updates. 

Upon study completion, BMA will perform study closure activities by collecting and reviewing all study close-out documentation, including updated financial disclosure documents, notifications to the IRB/IEC of study closure, drug accountability, and final site monitoring documentation. We will also liaise with your monitors to ensure that all final closeout documentation is collected prior to or at their final visit. We have found that this proactive approach to study closure ensures the most complete investigator files and significantly reduces the occurrence of missing documentation.

BMA can also create, maintain, and house Sponsor investigator files. We will manage the files according to your procedures and SOPs, returning them at the end of the study, or other specified time point, complete and regulatory compliant.

All of the above listed services can be performed with either paper documentation or through your electronic or web-based systems.

Regulatory

Regulatory Device