Global Certifications → Technical Skills → Career Success
GxP-Mandatory Training & Certifications (For All Job Roles in CR)
Don't just learn Clinical Research/ SAS /R/ CDM/ PV. Learn the industry first.
Your career starts with globally recognized regulatory certifications, followed by hands-on technical training. That's how you become not just trained—but truly industry-ready.
ICH-E6 R2 & R3
An international Good Clinical Practice (GCP) guideline that strengthens oversight of clinical trials through risk-based quality management, sponsor responsibilities, and computerized system controls also promotes quality by design, proportionate risk management, decentralized clinical trials, digital technologies, and participant-centric clinical research.
ICH E8 R1
An international guideline on General Considerations for Clinical Studies that emphasizes Quality by Design (QbD), identifying Critical-to-Quality (CtQ) factors, and planning clinical trials to generate reliable, ethical, and fit-for-purpose evidence throughout the product lifecycle.
21 CFR Part 11
A U.S. FDA regulation that establishes the requirements for electronic records and electronic signatures, ensuring they are trustworthy, reliable, secure, and legally equivalent to paper records and handwritten signatures.
21 CFR Part 312
A U.S. FDA regulation that governs Investigational New Drug (IND) applications, outlining the requirements for conducting clinical trials, sponsor and investigator responsibilities, protocol compliance, safety reporting, and FDA oversight before a drug can be marketed.
21 CFR Part 312.32
A U.S. FDA regulation that specifies the requirements for IND safety reporting, including the timely reporting of serious and unexpected suspected adverse reactions by sponsors to the FDA and clinical investigators.
Data Integrity (ALCOA+)
A set of principles that ensures clinical and regulated data are Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available, maintaining the reliability, traceability, and quality of data throughout its lifecycle.
Data Privacy (HIPPA)
HIPAA (Health Insurance Portability and Accountability Act): A U.S. law that establishes standards for protecting the privacy, security, and confidentiality of patients' protected health information (PHI) while ensuring secure handling and sharing of healthcare data.
Data Privacy (GDPR)
GDPR (General Data Protection Regulation): A European Union (EU) regulation that governs the collection, processing, storage, and protection of personal data, giving individuals greater control over their information and requiring organizations to ensure privacy, security, and lawful data handling.
ICH E3
An international guideline that provides the standard structure and content for Clinical Study Reports (CSRs), ensuring consistent, complete, and regulatory-compliant reporting of clinical trial results to health authorities.
Eligibility
- Candidates Enrolled Into Specific Programs Have Free Access As A Part Of Training & Internship Curriculum
- Graduates & Post-Graduates from Pharmacy, Life Sciences, Science, Biotechnology, Microbiology etc. Looking To Build A Career In Clinical Research
- Anyone Who Wishes To be Regulatory Ready
E- Certification Badge
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