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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.
Services
- 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
28
SITES Inspected
11
THERAPEUTIC AREAS
20
PHASE II STUDIES
2
PHASE III-IV
8
PK STUDIES
13
CDS Credentials
| 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 |
| Nutraceuticals | GI Index |
| Diagnostic | Infectious diseases |
| Clinical Endpoint | Dermatology |
Regulatory Inspection History
| Sr. No | Regulatory Agency | Location | Therapeutic area | Inspection Timing |
|---|---|---|---|---|
| 1 | USFDA | Ahmedabad | Psychiatry | July 2012 |
| 2 | USFDA | Ahmedabad | Psychiatry | July 2012 |
| 3 | USFDA | Surat | Psychiatry | Sep 2015 |
| 4 | USFDA | Junagadh | Psychiatry | Apr 2015 |
| 5 | USFDA | Ahmedabad | Psychiatry | Jun 2018 |
| 6 | USFDA | Vijayawada | Oncology | Oct 2018 |
| 7 | USFDA | Surat | Oncology | Dec 2018 |
| 8 | USFDA | Vadodara | Oncology | Jan 2019 |
| 9 | USFDA | Bengaluru | Oncology | Jan 2020 |
| 10 | USFDA | Tamil Nadu | Oncology | Feb 2020 |
| 11 | NPRA | Junagadh | Psychiatry | Mar 2023* |
Investigator Base
CARDIOLOGY
171
ONOLOGY
131
PSYCHOLOGY
121
PEDIATRICS
120
OPTHALMOLOGY
111
DERMATOLOGY
110
ENDOCRINOLOGY
109
ORTHOPEDICS
100
NEUROLOGY
98
GASTROENEROLOGY
98
UROLOGY
94
RESPIRATORY
92
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.
