BRD – Biotechnology Research and Documentation – CRO
The organization specializes in the management of medical devices in accordance with national and European regulations; these are complemented by dietary supplements, foods for special medical purposes and cosmetics. BRD is oriented towards the management of clinical studies according to the standards of Good Clinical Practice (ICH/GCP) in compliance with its own SOPs and those of the Client
Necessary flexibility with respect to the customer's needs
Throughout all phases of the clinical trial process.
Professionals with many years of experience in clinical trial, clinical drug research, regulatory regulations, statistics and marketing
BRD stands out for the provision of the highest quality clinical development services, characterized by scientific rigor and personalized flexibility. Our team of highly qualified professionals, subjected to continuous training and updating, guarantees maximum competence in every phase of the process, adapting precisely to the specific needs of the Customer.
Qualified technical staff
Selected medical centers
Negotiation and finalization of economic agreements. Obtaining opinions and authorizations
Data Management Plan, Case Report Form (CRF), Development and maintenance clinical database
Reports to sponsor and Follow-up letters to Centers, Clinical Monitoring Plan based on risk assessment
Regulatory document preparation for CE and AC: Ensuring compliance and market access
search, review, and analysis of published sources to evaluate existing knowledge on a specific topic
Identification of sites and investigators for clinical trials, ensuring patient recruitment and regulatory compliance
Development of the Statistical Analysis Plan (SAP), Table, listing e figure (TLF), Data Monitoring Board
SAE report, periodic safety reports, retrieval of missing information and requests for clarification
Constant reporting, flexible budget models,
Biotechnology Research and Documentation (BRD) is a established organization aimed at providing high-level scientific services to the pharmaceutical, cosmetic and food industries and academic institutions