Distribution and Collection of Data Discrepancies
BMA will distribute and collect data discrepancy queries within an average of 7-14 days from clinical sites in the Americas and throughout the world. During the life of a clinical trial and, most importantly, at interim and final deadlines, the timely return of accurate data is crucial. BMA can help ensure that, through constant communication with clinical sites and monitors, your clinical trial is not jeopardized.
Serious Adverse Event Narratives and Reconciliation
Serious Adverse Event retrieval for timely reporting to Regulatory Authorities, as well as writing SAE Narratives and Reconciliation, are prepared according to sponsor specifications.
CRO Interaction and Monitoring
Through our extensive experience with major CROs, metrics for data management of study data can be developed, as well as monitored to ensure on-time delivery of clinical data to meet sponsor deadlines.
BMA has worked on clinical trials for the following indications:
Avoidance of Vascular Occlusion
Arrythmias
Hypertension
CHF
COPD
Wound Healing
Diabetes
Otitis Media
RSV
AECB
Pneumonia (CAP & Nosocomial)
Pyelonephritis
UTI
Sinusitis
Sinusitis Epidemiology
Herpes Simplex
Ovarian Carcinoma
Kaposi's Sarcoma
Small Cell Lung Cancer
Colorectal Cancer
Acute Myelogenous Leukemia
Multifocal Leukoencephalopathy
Lyme DiseasePediatric RLS
Sepsis
Breast Cancer
Coronary Heart Disease
Thromboembolism
Thrombocytopenia
Influenza Vaccine
HPV Vaccine
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