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Progressive Life Sciences uses a study-specific Case Report Form (CRF) that is applied to either teleform (fax-based) or remote electronic (web-based) data capture procedures. This technology provides flexibility for investigative sites. Third party providers often cannot provide the level of attention necessary to collect quality clinical data and hence most of our EDC is developed in-house.
Our drug supply management system tracks drug supply and expiry dates throughout the course of a study. The system has multiple safety features to notify our drug management team of expiry dates and order fulfillment. Through PLS Web portal, you can access information regarding orders, quantities and statusof your clinical material.
We use MySql to maintain all information pertaining to sites, investigators and subjects; an easy to use, client-based system which feeds real-time data to reports accessed through the PLS web portal or integrates the data with a sponsor's project management system.
In the event of a power outage, Progressive Life Sciences maintains reliable battery powered back-up systems that will automatically bring the system back online in less than thirty seconds. An alternate location in Ghaziabad, UP provides for uninterrupted service if, for some catastrophic reason, the main branch becomes inoperable.
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Our in-house biostatisticians provide analytical expertise for coordinating clinical trials and also consultation on a contract basis. Our statisticians are involved in trials from design to total analyses or published manuscript, and beyond. We provide accurate, clean and secure database on time.
Our biostatistical services include:
- Preparation of Stastical Analysis Plan (SAP)
Development of study design – Sample size for desired statistical power. Formulation of statistical analysis plan of protocols – i.e to describe both interim and final analysis strategies
- Consultation/Planning
In house biostatisticians and database managers provide consultancy on statistical problems and to clarify the statistical analysis plan to client/ authorities.
- Report Preparation
Summary of all statistical methodologies and results. Preparation of final report for submission.
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- Database & eCRF design (OpenClinica, SPSS, EpiInfo)
- CRF management
- Double data entry
- Electronic data capture
- Web based receipt of CRF
- Data validation and review
- Medical coding using MedDRA
- SAS® programming
- Data processing and migration
- Data generation for analysis
- Seamless data conversion
- Randomization and supply management for multi-center trials
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