Norwich Clinical Services

Norwich Clinical Services
Focusing on your Patients. Focusing on You.

Your Goals. Our Expertise.
Norwich Clinical Services is a global contract research organization for the pharmaceutical and biotech industries. Dedicated Norwich program management will guide your program from the initial stages of development through study-end reconciliation with specific focus on budget efficiency and schedule adherence.

Finding Solutions. Delivering Outcomes.
With a focus on improving outcomes for patients, Norwich partners with you to deliver visionary solutions with the highest level of quality and reliability, including:

• Comprehensive clinical services
• Targeted therapeutic experience
• Technology-driven capabilities
• Global research centers in North America, Asia and Europe

Services

Clinical Research Capabilities
Clinical expertise is the foundation of our business. Norwich staff have been conducting clinical studies for more than 20 years, including 2,000 biostudies that have resulted in successful regulatory submissions to FDA, EMA and numerous local agencies.

• Multiple hospital-based clinic locations
• Pharmacokinetics studies in healthy volunteers
• Drug metabolism studies
• Dose proportionality studies
• Multiple dose studies
• Experience in multiple dosage forms

Bioanalytical and Laboratory Services
Norwich Clinical Services provides quantitative measurements of active drug and/or metabolite in biological matrices. Our method development team is committed to developing methods with the lowest LOQs and quick turnaround time.

• Method development and validation
• Sample analysis
• LC-MS/MS-API 4000 UPLC
• HPLC & LC-MS/MS analysis of drug and metabolites in biological fluids

Pharmacovigilance Services
Norwich Clinical Services offers comprehensive, low-cost pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis.

• Signal detection analysis and risk mitigation programs
• Oracle AERS 24x7 call center monitoring
• FDA, EMA and CEE country submissions via eCTD utilizing eCentral
• Axway Synchrony Gateway for E2B exchange
• Large volume data migration capability

All Norwich clinical solutions are conducted in strict conformity with GCP, GLP and CFR part 11 compliance.

Technology

Norwich Clinical Services is focused to provide technology-driven solutions that facilitate clinical research programs and provide our clients with absolute privacy and data quality assurance. Clinical data management includes archival procedures that guarantee data security with compliance for international regulatory requirements.

Our technology platform includes:

• Oracle CTMS 8.5
• Oracle Clinical 4.5
• Oracle Remote Data Capture
• Oracle AERS 4.6.1
• Axway Synchrony Gateway
• MedDRA/WHOODD coding
• MedXview eCentral
• WinNonlin PK/PD modeling

Global Therapeutic Expertise

Norwich Clinical Services invests in capabilities and teams to help customers succeed and their patients live better. Our expertise is focused on targeted therapeutic areas:

• Cardiovascular
• CNS
• Dermatology
• Endocrinology
• Infectious Disease
• Nutritional Health
• Oncology
• Respiratory

Locations

Norwich Clinical Services operates clinical solution centers in North America, Europe and Asia to provide a full range of contract research programs, including:

• Norwich, New York
• Bucharest, Romania
• Reykjavik, Iceland
• Moscow, Russia
• Bangalore, India

Partnering with Norwich

Norwich Clinical Services invests in capabilities and teams to help customers succeed and their patients live better. To provide a full range of contract research programs, Norwich Clinical Services offers clinical solution centers in North America, Europe and Asia.

	Norwich Pharmaceuticals Company Brochure Norwich Pharmaceuticals is a full-service outsourcing provider of Rx and OTC pharmaceutical products with 120 years of experience in the production, packaging, quality assurance and distribution of solid dose, semisolid and liquid pharmaceuticals.
	Norwich Clinical Services Brochure Norwich Clinical Services is a global contract research organization for the pharmaceutical and biotech industries. Dedicated Norwich program management will guide your program from the initial stages of development through study-end reconciliation with specific focus on budget efficiency and schedule adherence. With a focus on improving outcomes for patients, Norwich partners with you to deliver visionary solutions with the highest level of quality and reliability.
	Pharmacovigilance Monitoring Services Brochure Norwich Clinical Services offers comprehensive pharmacovigilance services for pre-marketing product safety, post-marketing surveillance and data analysis. Norwich pharmacovigilance is comprised of three units: drug safety and surveillance (DSS) for all drug products, risk management strategy (RMS) and regulatory affairs (RA).
	About Norwich Video Passionate partner, innovative thinker, and customer-focused manufacturer – discover the Norwich of today and tomorrow.
	Norwich History Video Uncover Norwich from its earliest days to today.