Data Management
Data Management, Biostatistics, Medical writing incl. of final CSR
We at PhaseOn understand the importance and integrity of the data that leads to the success of any clinical study program. Right from the start of the study, our team of experts work closely with our clients to ensure that the robust Data Management Plan (DMP) is in place and is developed with highest standards of quality. This is supported by our team of expert biostatisticians to develop appropriate biostatistical programs to have a Statistical Analysis Plan (SAP) in place to ensure a combined positive outcome. The current teams have access to the most current technology programs and platforms to support regulatory submission. A strong internal QC process at each critical steps ensure consistence in the quality deliverables.
Phase-on offers a full range of data management services that can be combined with our existing statistical expertise to provide a value added offering to our clients. We handle clinical studies of all sizes, from Phase I – IV, in FSP Model as well as stand-alone projects. To accommodate each client’s project specifications, our clinical data management team can handle paper-based and EDC-based systems in all phases and platform
We offer the following data management and biostatistics services
- CRF design/consultancy
- Database design
- Data management plans/guidelines
- CRF management
- Data entry
- Fax-in capabilities for CRF receipt
- Data validation and review
- Medical coding (MedDRA)
- SAS® programming
- Data migration services
- Generation of analysis database
- Large trial capabilities
- Transparent/seamless data conversion
- Report generation
- Statistical analysis
- Medical writing
Generic drug development
Generic drug development includes conducting Patient PK endpoint studies and also provide support to generic companies for the independent monitoring of the typical BA/BE studies.
Quality Assurance
Offers access to highly experienced Quality Assurance personnel to ensure compliance and quality in all clinical studies. We also provide standalone QA and audit support services to clients as needed..
Investigator Identification
PhaseOn leverages robust feasibility data and a trusted network of ICH-GCP trained KOLs and investigators across India to ensure accurate site selection across therapeutic areas.