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:

• FDA's Drug and Device Regulatory Requirements
• Clinical Development Services
• Monitoring & Study Rescue
• Therapeutic Areas of Expertise
• Auditing Services

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.

• Regulatory strategies for:
• Drugs
• Devices
• Biologics
• Cosmetics
• Any "claims made" product
• Investigational plan development
• Investigator brochures (Reports of Prior Investigations)
• FDA meetings/meeting packages
• IND submissions and amendments
• NDA submissions and supplements
• 505(b)(2) strategies and submissions
• IDE/PMA submissions
• Interim, annual and final reports to the FDA
• Drug Master Files (DMF)
• Rx to OTC switch applications
• Orphan Drug Applications

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.

• Complete clinical trial management (Phase 1 through 4)
• BRADSTREET offers expert planning, regulatory advice, project management, and continuous communication with our sponsors.
• Project management
• Part of our specialized service is that all projects are managed by our senior executives.
• Protocol and case report form development
• Protocol and case report form development by scientific/medical professionals ensures the accuracy, completeness and clarity of these essential documents.
• Superior clinical study monitoring
• "Dirty data" consume time and money. Comprehensive, accurate monitoring is the key to clean data.
• Site evaluation
• Inclusion of potentially poor sites can jeopardize data quality. Avoid using poorly managed sites by experienced evaluation; such sites are eliminated before they make the final site list.
• Site initiation and training
• Our experienced Project Managers and Clinical Research Associates (CRAs) train and initiate sites creatively, comprehensively and repeatedly to ensure compliance with protocols.
• Data management
• Data entry is performed by highly experienced data professionals to obtain a clean database as quickly as possible.
• Biostatistics
• Our statistician is exceptionally experienced and highly respected by the FDA.
• Literature searches, abstracts, interpretations, meta-analyses
• Performed by scientists with advanced training in search techniques and writing.
• Medical and scientific writing
• We have a particular strength in this area. Bradstreet's clinical, regulatory and scientific writers have broad training and experience. They incorporate data and information from clinical and non-clinical sources, all within a framework of regulations and guidances, while writing with organization, style and format.
• Study salvage/rescue
• BRADSTREET has extensive experience in rescuing studies that suffered from poor compliance with protocols and/or regulations.

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:

• Site qualification
• Site initiation
• Site training and management
• Interim monitoring
• Site close-out

• Slide presentations for major medical meetings
• Journal article preparation
• *Registries
• Observational studies
• Patient experience studies
• Phase 4 and Surveillance studies

*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.

• Antiinfectives
• HIV/AIDS
• Candida vulvovaginitis
• Oropharyngeal candidiasis
• Hepatitis C
• Influenza
• Periodontal disease
• Sexually transmitted diseases
• Condylomata acuminata (genital warts)
• Genital herpes
• Skin/soft tissue infections
• Cardiovascular
• Venous thromboembolism
• Cholesterol lowering drugs
• Dental caries studies
• Oncology
• Lung
• Melanoma
• Ovary
• Breast
• Colon
• Prostate
• Venooclusive Disease (VOD)
• Neurology
• Migraine/headache
• Pain/analgesia
• Internal Medicine/Endocrine
• Fecal fat studies for pancreatic insufficiency
• Respiratory
• Cystic fibrosis - mucus clearance
• Chronic lung infections
• Women's Health Care
• Traditional hormonal contraception
• Emergency contraception
• Menorrhagia
• Endometrial thermal ablation
• Pelvic inflammatory disease
• Assisted reproduction/In vitro fertilization (IVF)
• Vulvovaginal infections
• Sexually transmitted infections
• Cervical ripening/Labor induction
• Adhesion prevention after gynecological and general surgery
• Wound Care
• Diabetic foot ulcers
• Pressure (decubitus) ulcers
• Venous stasis ulcers
• Ostomy wound care
• Chronic and dehisced wound care
• Non-healing surgical wounds

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.
BRADSTREET has considerable experience in performing the following audits:

Regulatory Compliance Audits

• cGCP compliance
• Preparation (for-cause) investigator audits
• Clinical data
• Clinical study reports
• Mock FDA inspections
• SOP evaluation / SOP development
• Corrective and preventive action plans

Pharmaceutical Due Diligence Audits

• Pre-merger, co-development investments
• CRO/Vendor evaluations
• Clinical development evaluations
• Risk assessment

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