Pharmaceutical

1. Clinical Studies

Our dedicated team of experts will take care of different clinical phases and post-marketing survey. These clinical trials are according to and under the strict guidelines of CTRI (India).

Preclinical

- Clinical development planning

- Regulatory consulting

- Protocol design

- Expert panels

Phase I

- First introduction into man

- PK/PD studies

- Single-dose, multiple-dose, and dose-escalation studies

- Special studies (e.g. food interaction; skin irritation)

Phase II a

- Proof-of-concept studies

- Dose-ranging studies

Phase III

- Large-scale global safety and efficacy studies

- Placebo-controlled studies

- Active-comparison studies

- Bioequivalence studies with clinical endpoints

- Quality-of-life studies

- Resource utilisation studies

Registration/Phase III b

- Individual study reports

- Integrated safety and efficacy summaries

- Treatment INDs

- Package inserts

- Submissions in NDA or CTD formats

Phase IV

- Post-approval regulatory commitments/support for primary indication - New indication studies/labeling expansion

- Medical Information & Professional Contact Center

- Registries and Observational studies.

- Health-related quality of life, patient-reported outcomes via IVRS

- Post-marketing surveillance

- Product Safety and Pharmacovigilance.

- Retrospective chart reviews

- Managed-care studies

- Pharmacoeconomics

2. Pharmacovigilance

- ICSR Case processing

- Literature processing

- Device case processing

- Aggregate reporting: PSUR

- DSUR

- PADER

- Clinical Overviews

- Risk Management

- Reference Safety information

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