Clinical Development Services
We offer Phase II to IV studies for small and large molecules and post-marketing surveillance and nutraceuticals. Our team is dedicated for providing the highest quality research and data analysis in these areas.
- Phase II-IV
- Therapeutic equivalence
- Clinical endpoint
- Post-marketing surveillance
- Clinical Site Monitoring
- Data management
- Biostatistics and Programming
- Medical writing
Clinical Development Services in numbers
STUDIES TILL DATE
PHASE II STUDIES
|Study Type||Therapeutic Area|
|Phase II||Gynecology, Infectious diseases|
|Phase III||Dermatology, Psychiatry|
|Phase IV||Cardiology, Infectious diseases, Oncology, Neurology, Respiratory|
|PK||Orthopedic, Psychiatry, Oncology, Hematology|
Regulatory Inspection History
|Sr. No||Regulatory Agency||Location||Therapeutic area||Inspection Timing|
|10||USFDA||Tamil Nadu||Oncology||Feb 2020|
Clinical Trial Management
- Monitoring: Involves the supervision and oversight of clinical trial activities at investigational sites to ensure compliance with study protocols and regulatory requirements.
- Data management: Involves the collection, processing, and analysis of clinical trial data. We ensure that data is accurately captured, securely stored, and readily accessible for analysis and reporting purposes.
- Medical writing: Involves the development of essential clinical trial documents such as protocols, informed consent forms, and clinical study reports. These documents are crucial for regulatory submissions and scientific publications.
- Site management: Entails selecting, initiating, and supporting investigational sites participating in clinical trials. The CDS department liaises with site staff, provides training, and ensures proper site performance and compliance.
- Project management: Involves the overall planning, coordinating, and execution of clinical trials. The CDS department oversees timelines, resources, and budgets to ensure efficient and successful trial conduct.