1. Clinical Regulatory Services

Clinical Trial Submissions

• Clinical Study Design
• Sample Size Estimation
• Protocol Synopsis
• Protocol Development
• Informed Consent Form
• Advertising Material
• Insurance and Indemnities Advice
• Investigator’s Brochure

Clinical Trial Management

• Pharmacy Manual
• Laboratory Manual
• Statistical Analysis Plan
• Medical Monitoring Plan
• Safety Management Plan
• Data Management Plan
• Medical Writing Plan

Clinical Study Reports

• Clinical Evaluation Reports (CERs)
• Development of TFLs
• SAS programming for TFL’s
• SDTM and ADaM compliant datasets

Regulatory Interactions

• Scientific Advice / Briefing Book
• CTD Sections
• Risk Management Plan
• Post Market Surveillance (PMS) Plans

2. Scientific Writing and Publishing

Manuscript Writing

• Original Research Article
• Review Article Preparation
• Guideline Development
• Scientific Poster
• Oral Presentations
• Publication Management

Journal Selection

• Journal Submission
• Journal Resubmission
• Journal Formatting
• Global and Regional Publication Plan
• Editing & Proof Reading

English Check

• Data Fact Check
• Medical Review
• Proof Reading
• Reference Tagging and Uploading