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Services

Clinical Research Services

Edenwell’s Clinical Research group, analogous to the full service Contract Research Organization (CRO) specializes in providing end-to-end clinical development services for phase I to phase IV in the drug development process of Pharmaceutical and Biotechnology companies.

The primary emphasis is to conduct studies on time, within minimum budget and in accordance with local and international guidelines.

The company focuses on clinical excellence from Proof of Concept Trials through the delivery of pre-marketing and pivotal trials to post-registration support.

Regulatory Affairs
  1. Clinical trials dossier preparation & submission
  2. BABE studies dossier preparation & submission
  3. Import & Export license
  4. Preparation & attending SEC, DSMB, CBBDTEC, SAE committee meetings
  5. Coordination & follow up with regulatory agencies
Clinical Operations & Project Management
  1. Clinical development program consulting
  2. In depth feasibility studies and risk assessment plans for country evaluation
  3. End to end Project Management for global and local trials using CTMS
  4. Critical inputs for study design and protocol writing
  5. Clinical Monitoring
  6. Study Metrics reporting
  7. Site training
  8. Safety Monitoring
  9. Risk-based Monitoring
  10. Vendor management
Clinical Data Management & Biostatistics
  1. CRF Designing & Validation
  2. Database Designing & Validation
  3. Sample Size calculation & Justification
  4. Preparation Randomization Schedule
  5. Preparation of Data Management Plan
  6. Development of Statistical Analysis Plan
  7. Creation of analytical datasets
  8. Programming of tables, figures and listings
  9. Statistical interpretation of results
  10. Statistical report development
  11. Interim analyses
  12. Development of clinical study report
  13. Statistical coordination and report writing
IP Management & Logistics
  1. Import of trial supplies / customs clearance
  2. Comparator drug sourcing
  3. Various types of randomization systems (E.g. IWRS/IVRS)
  4. Keeping a check on the distribution channels
  5. Monitoring the entire supply chain with strict inventory management mechanism
  6. Ensuring that each patient gets the correct IP
  7. Shipment to sites and retrieval of supplies from investigator sites
  8. end-to-end clinical trial supply solutions
Quality Assurance
  1. SOP writing
  2. Clinical Investigator Site Audits
  3. Sponsor Audits
  4. Systems Audits
  5. Adverse Event Reporting System Audits
  6. Database and Data Management audits
Medical Writing

Our expertise in providing quality documents includes the following

Clinical Documents

  1. SOP writing
  2. Clinical Investigator Site Audits
  3. Sponsor Audits
  4. Systems Audits
  5. Adverse Event Reporting System Audits
  6. Database and Data Management audits

Regulatory Documents

  1. Product Monographs
  2. Risk Management Plans (RMP)
  3. Patient Package Inserts
  4. Summary of Product Characteristics (SmPCs)
  5. INDs, NDAs, MAAs and other international drug submissions
  6. Briefing documents for agency meetings

Pharmacovigilance Documents

  1. Periodic Safety Update Reports (PSURs)
  2. Special safety reports
  3. Expert Overviews/Reports
  4. Publications and Other Documents
  5. Manuscript preparation
  6. Posters and platform presentations
  7. Field force training documents and slides
  8. Regulatory guidance and review of advertising/promotional materials
Drug Safety & Pharmacovigilance

SAE Management and reporting

  1. 24/7 medical and safety coverage
  2. Trial-specific SAE report form including clear completion guidelines for the investigator
  3. Pharmacovigilance training to trial personnel
  4. SAE/ADR management
  5. Expedited Reporting
  6. Literature search
  7. AE/SAE reconciliation between the clinical database and the safety database at trial closure

Periodic Safety Reports

  1. Safety Risk Management Plans (RMP)
  2. Periodic Safety Update Reports incl. a benefit –risk section
  3. Annual Safety Reports and Drug Safety Update Reports (ASRs/ DSURs)
Bioavailability & Bioequivalence
  1. We help choose the best CRO for your BA/BE, PK studies and early development studies.
  2. Our network of study centers that carry out Bio-availability / Bio-equivalence/ Pre-Clinical are approved by various regulatory agencies.
  3. Clinical Trial Monitoring Work for BABE studies in India and abroad for sponsors from India and abroad
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