CLINICAL TRIALS & SERVICES
Adore Research offers a range of preclinical drug development services including IND & NDA enabling studies, Impurity qualification & Bridging studies for regulatory submissions & 505 (B2) strategies in-
- Herbal Formulations and Ayush
- Medical Devices
- Homeopathic and Unani medicines
Our expertise in safety evaluation spans across DMPK, genetic toxicology, mammalian toxicology, formulation & bio-analysis including method development & validation.
- Develop clinical trial protocols and/or investigational plans
- ICF Development with local language translations
- Standard Operating Procedure (SOP) and Work Instruction (WI) development
- Case Report Forms for Paper And EDC studies
- Investigator Brochures
- Essential Documents
Investigator /Site Management:
- Liaison between investigational sites, and CROs
- Project Management Activities
- Ethics Committee Management
- Monitor Activities
- Site Coordination for data collection and query management
Case Study Report (Clinical Study Report) Services:
- Conduct basic statistical analyses for technical support of molecule.
- Generate clinical study reports.
- Conduct literature reviews.
- Evaluate and report on adverse events associated with the molecule.
Clinical Trial Project Management:
- Manage site feasibility, recruitment/selection
- Conduct investigator meeting
- Management of clinical study site
- Ethics Committee Submissions
- Oversee project budgets, budget change forms, accruals, and monthly reports
- Archival of Clinical Study Records
Clinical Research Training and Certification
- ICH-GCP Guidelines
- Indian GCP Guidelines
- E6 Guidelines
- Schedule ‘Y’