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-

• Pharmaceutical
• Biopharmaceutical
• Nutraceutical
• 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.

Clinical Development:

• 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

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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’