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