PK | Biostatistics
PK | Biostatistics Team is competent and offers accurate statistical analysis for BA | BE studies and Phase II-IV clinical trials.
We at Revive position ourselves for NDA, 505(b)(2), and ANDA filings by offering combined project execution with clinical and bioanalytical operations, with complex studies of phase I and other related global industry projects.
Phase I study for your clinical/bioanalytical research needs
- First in Human Pharmacokinetic/Pharmacodynamic studies
- Single Ascending Dose (SAD) & Multiple Ascending Dose (MAD)
- Drug/Drug Interaction (DDI) & Food Effect
- Gender and Age Effect
- Renal Impaired & Hepatic Impaired Studies
- Cardiac Safety & Cognitive Assessment Studies
- Phase I sufficiency hospital beds, oximetry, ECG monitoring, vials and as needed
- Independent volunteer recruitment center
The integrated capabilities can help you minimize risk, ensure trial feasibility and drive regulatory and commercial success of your program.
The well-trained and highly qualified professionals in clinical trial monitoring across various Phase II – IV studies in different therapeutic areas, who work on close association with clinical investigators in each research site to execute the projects effectively.
Revive offers a full range of clinical research services for the pharmaceutical, medical device, biopharmaceutical and CRO industries including:
- Study Development
- Site Qualification & Site Initiation visit
- Interim monitoring & Site Close out visit
- Intellectual Advisory Board
- Translational Science Specialists
- Medical legal services
Additionally, we prove conduct of a New Drug Application (NDA) and Biologics License Application (BLA) clinical studies across range of therapeutic areas for vast study types with diverse healthy volunteers and patient population.
The diversely experienced personnel bestow intuition into trial design, develop complex statistical analysis plans and support clients throughout the regulatory filing process.
Biometrics services include protocol writing, statistical analysis and report writing. Biometrics Division is well equipped with the latest software like Win NonLin and SAS (SDMS & MED X view).
Biostatistics team is capable of handling amendments in Sponsor requirements and is swift to respond, striving for complete satisfaction with the best quality or timelines. The services include:
Database Programming
- CRF Design (paper & electronic)
- CRF Annotation
- Database Programming
- Validation Checks
Data Management
- Data Acquisition
- Data Reconciliation
- Discrepancy Management
- Medical Coding (MeDRA & WHODD)
- Database Lock
- Data Extraction for Reporting
Biostatistics
- Randomization
- Sample size estimation
- Trial Design Inputs
- Statistical Analysis Plan
- Statistical Analysis
- Biostatistics Subject Matter Expert (Tie up with global consultants)
Statistical Reporting
- TLF Programming
- CDISC Data Mapping (SDTM & ADaM)
- Clinical Data Repository
- Safety (ADR) Reporting
- Patient Profiles & Data Cleaning Reporting
- Feasibility analysis
- SAP & TLG|F mock shell preparation | CDISC | SDTM | ADaM standards
- Uploading for EDC | Blinded envelops
- Evaluate and provide preliminary statistical analysis & reporting
Stay informed about the up-to-date statistical techniques approved by regulatory authorities such as USFDA, EMEA and DCGI