Study Management

Assist with Feasibility and Site Selection Activities

BMA will work with you, the Sponsor, to help find and determine the most eligible and appropriate clinical sites for a trial. We will also contact sites to determine interest and feasibility, as well as assist with Confidentiality Disclosure Agreements.



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.



Tracking, Collating and Follow-up on Vendor and Study Data

BMA will collect, track, collate and follow-up on data supplied by Sponsor-utilized vendors. BMA can also perform the same tasks for global study data.



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.



Distribution of Study Wide Correspondence

Throughout the life of a 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 discrepancies are noted, BMA will retrieve and/or document all missing items.



IP Temperature Monitoring (Cold Chain)

Ensuring that investigational product being stored at sites is maintained at the appropriate temperature is critical. BMA will work with sites to evaluate cold chain capability and monitor IP temperature and any deviations throughout the life of the clinical trial. BMA will also work with the study team and site to control deviated IP, determine the cause of the deviation, develop corrective actions to address the deviation and monitor study sites for compliance.



FDA Submission Support

FDA submission can be a stressful and challenging time. Let BMA be your helping hand. BMA will support your team during this time by reviewing and perfecting regulatory documents, investigator, country and central files, as well as support sites that face a potential audit.



Meeting Planning

Depending on your needs, BMA can act as your liaison between the selected meeting planner and sites, or we can take on the full responsibility of planning your Investigator, Study Coordinator, Monitor, or general company meeting.

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