“We possess the scientific expertise and operational excellence to successfully execute the most challenging studies.” - Mala Srivastava, Head - Business Strategy

Clinical Operations

- Study Management
- Site Management
- Clinical Monitoring
- Clinical Trial Supply Management


Clinical Development

- Conceptualization of Study Design
- Study Documents Preparation & Review
- Medical Writing
- Medical Management
- Medical Monitoring, Safety Data Handling & Reporting


Clinical Data Management & Biostatistics

- Case Report Forms (CRF) Design Development
- Database Design & Development
- Data Entry & Data Validation
- Query Management
- Coding of Adverse Event & Concomitant Medication [MedDRA   & WHO-DD]
- Reconciliation of Serious Adverse Events
- Protocol Input for Statistical Section
- Sample Size Calculation, Randomization & Blinding
- SAS Coding, Statistical Analysis & Report Generation


Regulatory Services

- Regulatory Services across the New Drug Development   Process (small molecules, biologicals, monoclonal antibodies)
- Regulatory Services for Generics / Biosimilars
- Marketing Authorization
- Preclinical & Clinical Development
- Marketed Products Regulatory Compliance


Human Pharmacology Unit

- Proof of Concept Studies
- PK/PD & BA/BE Studies for various Dosage Forms
- Dose Ranging Studies
- Phase I/First-in-Human Studies


Bioanalytical Research Laboratory

- Method Development & Validation as per US FDA guidelines
- Analysis of Drugs and/or Metabolites in Biological Specimens   to support PK, BA/BE & TDM Studies
- Preparation & Review of Bioanalytical Reports for BA/BE   Submissions


Central Laboratory

- Biochemistry
- Hematology
- Histopathology
- Microbiology
- Clinical Pathology
- Special Tests