Clinical Trial Related Services
With greater emphasis on clinical research the demand for authentic and high quality data for analysis and regulatory submission is witnessing an increase as well.
We offer end-to-end solutions for:
- CRF DESIGN
- PROTOCOL REVIEW AND INPUT FROM AN ANALYSIS AND SUBMISSION PERSPECTIVE
- CLINICAL DATA MANAGEMENT
- BIOSTATISTICS
- MEDICAL WRITING
Our expert panel of data managers, biostatisticians and Medical Writers will consult with you at the protocol design stage for greater reliability and effectiveness.
State-of-the-art 21 CFR part 11 compliant technology and multi-skilled resources with in-depth knowledge of international regulatory requirements, such as ICH GCP regulations, GCDMP and the CDISC CDASH and SDTM models, ensure the safety and reliability of your data.
We offer our services for Paper-Based and Electronic Data Capture trials.
Our data centre, located in India, offers skilled resources, state of art technology and cost efficiency. Oracle Clinical, Merge’s user-friendly clinical OS and Medidata Rave are a few amongst a multitude of globally renowned platforms provided. The ECD platforms are on secure cloud technologies, compliant to 21 CFR Part 11.
Our Clinical Data operations are designed based on Total Quality Management approaches that focus on Error Prevention and Continual Improvement. With top – five pharmaceutical companies and leading generics manufacturers amongst our satisfied customers, we look forward to ensuring Customer Satisfaction and Confidentiality.
TRAINING PROGRAMS
Corporate Training Programs:
These short duration courses add value to operations and introduce quality concepts to clinical trial personnel. Our programs are aimed at investigators and site personnel, Clinical Data Coordinators and Project Mangers and cover a variety of topics including:
- REGULATORY COMPLIANCE
- EFFECTIVENESS OF OPERATIONS
- QUALITY ASSURANCE
Our corporate training programs can be customized.
Academic Training Program on Clinical Research and Data Management:
Automation has its limitations, as competent work force is essential to produce high quality data. Our academic training program is aimed at equipping students and professionals with the skill sets required to add value in the Clinical Trial industry.
The program is designed to balance theory with a simulated real work environment in order to minimize induction time and on-the-job errors. Having trained over 100 students in the last three years, several are now pursuing careers with global CROs and IT-enabled service providers.