Pharmacokinetics and Statistics

• Consulting
• Study Design Development
• Statistical Plan Development
• Pharmacokinetic and Pharmacodynamic Analysis
• Statistical Analysis
• Toxicokinetics for Preclinical Studies
• SAS Code Programming
• Consultation with FDA, TPD, EMEA
• Data Analysis Plan

Protocol Writing

Based on sound study design, detailed product information, and our cumulative research experience, Biovail can develop a study protocol and consent form for your study. We can also work with a client-supplied study protocol and consent form, and provide input, upon request.

Report Writing

• Integrated Study Report
• Clinical Report
• Analytical Report
• Statistical Report
• Preparation of FDA Summary Tables for ANDA Submissions.
• Custom format reports
• CD-ROM copy and hard copy of reports and associated study data
• Multiple copies of reports
• CS-BE preparation for TPD submission
  

The final integrated study report is the final deliverable that Biovail Contract Research provides its clients, so our goal is to issue this report in the shortest possible time.

Our standard reports are prepared to conform to requirements of the ICH, FDA, TPD, and EMEA. Past experience and regulatory expertise ensures that reports are written to minimize any possible delay in regulatory approvals.

Clinical Data Management

• CFR Development
• Database Design
• Data Management Plan
• Safety Data Entry & Tabulation
• Data Analysis
• DCF Management
• Electronic Transfer (SAS Export Files)

Quality Assurance (QA)

The main focus of QA is to be an objective monitor of the research activities that are conducted at Biovail Contract Research, and to ensure compliance to governing SOPs, GCP, GLP and ICH guidelines, and regulations. Other key activities include:

• Coordinate all regulatory inspections and applicable client audits
• Control revisions to Standard Operating Procedures and applicable forms
• Conduct annual internal facility audits, procedural inspections and study monitoring
• Ensure swift, seamless adoption of regulatory procedure modifications, as required
• Coordinate training and regulate issuance of divisional training materials
  

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