Clinical Research

Clinical Trial Design
& Monitoring

Design & Execution of

ICH-Compliant Protocols
We monitor clinical trials with strict adherence to ICH guidelines and local regulations, delivering protocols for:

• Phase I–IV Trials

• Bioequivalence, Bioavailability & Pharmacokinetics (BA/BE/PK) Protocols

• Biosimilarity (Biocomparability) Protocols

• Real-World Evidence (RWE) & Real-World Data (RWD) Protocols

Final Study
Reporting

Regulatory-Ready

Documentation
Developed in full compliance with ICH standards and local requirements:

• Final Clinical Study Report (CSR)

• Final Statistical Report

• Interim & Final Safety Reports

• CTD Dossier Integration for Regulatory Submission

Operational
Documents

Compliant,

Audit-Ready Materials
Crafted to meet GCP, GLP, ALCOA+, Helsinki Declaration, and ARCO rights standards:

• Standard Operating Procedures (SOPs) for Sponsors, Sites & CROs

• Investigator’s Brochure (IB)

• Pharmacy Manual

• Patient Diaries/Booklets

• Training Manuals

• Case Report Forms (CRFs)

• Informed Consent/Assent Forms

• Pregnancy Prevention Agreements

• Patient Recruitment Materials