Explore Our Clinical Solutions
Biostatistics & Data Management
Expert statistical analysis and robust data management solutions for reliable research outcomes.
At ABS Clinical Solutions, our Biostatistics and Data Management teams are integral to the success of your clinical studies. We provide rigorous statistical expertise and robust data management soluti...
- Study Design & Protocol Development
- Statistical Analysis Planning (SAP)
- Advanced Statistical Programming (SAS, R)
Clinical Trial Management
Comprehensive management of clinical trials from Phase I to IV, ensuring adherence to global standards.
Our comprehensive clinical trial management services cover all phases of drug development (Phase I-IV), medical devices, and diagnostics. We understand the complexities of clinical research and are co...
- Phase I-IV Clinical Trials
- Medical Device & Diagnostics Studies
- Global Regulatory Compliance (ICH-GCP, FDA, EMA, CDSCO)
Independent Ethics Committee Approval
Welcome to our Independent Ethics Committee (IEC), constituted in accordance with the guidelines of the Central Drugs Standard Control Organization (CDSCO) and the provisions of Schedule Y of the Drugs and Cosmetics Rules, 1945.
Our IEC is dedicated to safeguarding the rights, safety, dignity, and well-being of research participants involved in clinical trials and biomedical research. The committee independently reviews, appr...
- Regulatory Compliance under CDSCO, Schedule Y, NDCT Rules, and ICH-GCP.
- Multidisciplinary Expert Committee with medical, scientific, legal, and lay members.
- Strong focus on participant rights, safety, and well-being.
Medical Writing & Publications
Clear, concise, and scientifically accurate medical writing for diverse clinical documentation.
High-quality medical writing is essential for effective communication of scientific and clinical data. ABS Clinical Solutions offers comprehensive medical writing and publication services, transformin...
- Clinical Study Protocols
- Investigator's Brochures (IB)
- Clinical Study Reports (CSR)
Pharmacovigilance
Proactive drug safety monitoring and comprehensive adverse event reporting for patient well-being.
Ensuring patient safety is paramount in drug development and post-marketing. ABS Clinical Solutions provides robust pharmacovigilance services, offering comprehensive drug safety monitoring and advers...
- Adverse Event (AE) & SAE Processing
- Expedited Reporting to Authorities
- Aggregate Report Writing (PSUR, DSUR)
Quality Assurance
Rigorous quality assurance processes to uphold the highest standards of research integrity and data quality.
Quality is at the core of everything we do at ABS Clinical Solutions. Our independent Quality Assurance (QA) services are designed to ensure that your clinical trials, data, and processes adhere to th...
- GCP, GLP, GMP Audits
- Investigator Site Audits
- Vendor & System Audits
Regulatory Affairs & Compliance
Navigating complex regulatory landscapes to ensure seamless approvals and adherence to compliance.
Navigating the complex and ever-evolving global regulatory landscape is critical for successful clinical development. ABS Clinical Solutions provides expert regulatory affairs and compliance services ...
- Regulatory Strategy & Consulting
- CTA/IND/NDA/MAA Submissions
- Health Authority Liaisons
