Clinical Trial Designing Services
Designing a clinical trial and its documents are one of the most important step of clinical research. Deep understanding of therapeutic area and thorough understanding of various regulatory requirement are required for the same. We at ClinNext is having expert team and we offer following clinical trial designing services.
- Setting up Primary and Secondary Objectives of Clinical Trial
- Defining Key Inclusion and Exclusion Criteria of Clinical Trial
- Defining Dose Limiting Toxicity for Escalating Dose Clinical Trials
- Defining Dose Escalation Rule and Designing Dose Escalation Procedures
- Protocol Synopsis Designing
- Clinical Trial Protocol Designing
- Clinical Evaluation Plan (CEP) Designing
- Informed Consent Document (ICDs) Designing
- Case Record Forms (CRFs) Designing
- Investigator’s Brochure (IB) Designing
- Various Logs and Forms Designing
- Source Document Templets Designing
- Clinical Trial Steering Committee Charter / SOP
- Data Safety Monitoring Bord Charter / SOP