The Bradstreet Way
BRADSTREET is a privately-owned consulting organization located in the heart of the Northeast's pharmaceutical industry. We focus on clinical research and regulatory affairs, specializing in the following areas:
BRADSTREET also specializes in conducting patient registries, Phase IV studies, retrospective studies, and large simple trials of varying designs. The resulting data may be used to help physicians improve their prescribing practices and to obtain supplemental indications to existing NDAs.
Successful clinical studies must be performed in compliance with the FDA's ever evolving regulations. Our regulatory staff has the knowledge, experience and skills required to advise and manage all regulatory aspects of your clinical development program, optimizing the profile of your product in your regulatory submissions. As regulatory requirements become more rigorous, we work closely with you and the FDA to prepare successful regulatory strategies and submissions. Our services begin with clinical development and continue throughout the clinical trial phases, including submission preparation and through to FDA approval. If you need to meet with the FDA we offer complete FDA meeting preparation services, including planning, rehearsals and meeting management.
Our regulatory services include:
Clinical Development Services
BRADSTREET has extensive experience in all phases of pharmaceutical development, from Phase 1 through 4. Depending on your needs, we can either supplement your staff, or manage all aspects of your clinical programs and submissions. Our dedication to personal service and excellent project management will ensure the timely and successful clinical development of your product.
Our clinical research services include:
Monitoring & Study Rescue
BRADSTREET maintains a local and national network of experienced monitors additionally trained by our clinical and regulatory professionals. Our monitors have a broad range of therapeutic expertise enabling them to ensure the appropriateness of your clinical data as well as site compliance with cGCPs, FDA standards, IRB requirements and ICH guidelines.Data Quality Assurance
Complete and correct study data provide the true profile of a drug or device. The key to high quality data is high quality monitoring. Our clients will attest that BRADSTREET monitored data are the most complete and cleanest they have obtained. Hands-on management by BRADSTREET senior staff members is the key to successful monitoring in accordance with Good Clinical Practices.Clinical Study Rescue/Salvage
Good studies with inherent value are often endangered as a result of inadequate monitoring and oversight. Proper corrective action can often save these studies. BRADSTREET has marked success in study rescue. Sometimes NDA supplements can be based on the accumulation of existing data. We can help you design a protocol for retrospective data retrieval and provide you with operational and regulatory assistance for the gathering and reporting of your data.
Our monitoring services include:
*Registries gained additional credibility when the New England Journal of Medicine published a review article demonstrating that retrospective observational studies, utilizing existing medical databases generated after 1984, did not show qualitatively different drug efficacy when compared to data from prospective, randomized controlled trials. These comprehensive databases are increasingly being used to direct additional product development, provide sales and marketing information and sometimes to fulfill FDA obligations to conduct Phase 3b and Phase 4 studies.
BRADSTREET has the experience and expertise needed to design and implement these large simple trials. We will help you create these data for the clinical and commercial uses you have in mind. Our most recent registry study for a major pharmaceutical company was the largest of its kind and performed a great public service. The data obtained alerted the medical community to the absolute need to provide surgical and other patients with sufficient anticoagulant medication to prevent deep vein thrombosis and possible pulmonary embolism.
Therapeutic Areas Of Expertise
Post monitoring audits of your clinical data can help avoid delays
in getting a new product to market. Auditing clinical data prior to
an initial public offering, merger or acquisition is also a good investment.
Regulatory Compliance Audits