Clinical Research Expert Consultancy Services
Clinical research is to support the development of new therapeutic products and hence, the Sponsor, the owner of the therapeutic product always needs an expert opinion and support for their various clinical research programs. We at ClinNext being expert and experienced professionals in this area offers the following services for the same.
- Clinical Development Strategy Designing for the Therapeutic Product
- Interpretation of Pre-clinical Research data in order to make “Go” or “No-Go” decisions
- Setting up Primary and Secondary Objectives of Clinical Trial
- Finding FDA Accepted and Validated Clinical Trial Variables and Endpoints
- Defining Validated Procedures for Measurement of Clinical Trial Variables and Endpoints
- Method Designing and Validation for Clinical Pharmacodynamics Assessments
- Quantitative Clinical Pharmacology Services
- Modelling and Simulation Services
- Independent Clinical Trial Steering Committee Services
- Independent Medical Monitoring Services
- Third Party Monitoring and Due Diligence
- Outsourcing Support by Vendor Identification, Vendor Qualifications, Budget / Quotation Review, Vendor Selection, Periodic Vendor Audit etc.