Study Management
Preparation and Distribution of Study Initiation Packets
BMA will reproduce and prepare study initiation packets & regulatory binders and distribute them to clinical sites. Accurate and on time shipments ensure that your clinical trial will meet the best possible start
Collection of Regulatory and Financial Documentation
BMA will work with clinical sites to collect all regulatory and financial documentation required for study start-up. We recognize that one of the most critical steps of the clinical trial process is ensuring that sites are ready for initiation as soon as possible.
BMA will also collect ongoing documentation throughout the duration of the clinical trial. This includes, revised 1572s, certification renewals, annual/semi-annual IRB renewals and all documentation relating to amendments and modifications. Once documents are collected from clinical sites and reviewed and approved by BMA, they can be returned to the Sponsor, or filed and retained in our office until the end of the study.
Upon study completion, BMA will collect all study close-out documentation, e.g. Finanical Disclosure Forms Part B, Notification to IRB of study close-out, etc.
Negotiation of Clinical Study Agreements and Per Patient Budgets
BMA will produce, distribute and negotiate Sponsor approved Clinical Study Agreements and Per Patient Budgets. Using pre-specified guidelines, we will work to negotiate the best possible budget on behalf of the Sponsor.
Review and Approval of Informed Consent Forms
Using FDA and Sponsor specified guidelines, BMA will work with clinical sites to ensure that all required Informed Consent Forms contain the appropriate language and information. Distribution of Study Wide Correspondence
Throughout the clinical trial, BMA will reproduce and distribute study-wide correspondence on behalf of the Sponsor.
Regulatory Document Audits
BMA will review study and investigator files for correct and complete content. Once discrepancie