Our educational programs are designed to cover international and local regulations. It is in compliance with US-FDA regulations. CKTRI has exclusive partnership with Kriger Training & Research Centre Pvt. Ltd. to conduct its educational programs in India. The certificate programs offered by CKTRI in conjunction with Kriger are globally recognized and accepted.

Students will benefit from our programs through:

*In-class sessions and e-learning (online sessions offer convenient learning)
*Hands on training with live projects for clinical monitoring in Phases I-IV, protocol design, CRF, ICD
*GCP ICH certification which carries worldwide recognition in the biopharmaceutical industry
*Program certification which are recognized by our affiliates (IBPA, ACRP, SoCRA, APPI)
*Soft skills enhancement and personality development training (resume writing and interview skill enhancement)
*Internship Program with partner hospitals and institutions (gain practical knowledge and experience)
*Strong placement support

Our Certificate Programs:

C001      Clinical Research Associate Program
C002      Clinical Data Management
C003      Quality Assurance & Regulatory Issues
C004      Biopharmaceutical Marketing and Management Program
C005      Clinical Investigator Program
C006      Medical Writing
C007      Statistical Software Programming

Our Dual Certificate Programs:

DC001   Clinical Research Associate + Data Management Program

Our PG Degree Programs:

M.Sc. in Clinical Research (IV semester)

Our PG Diploma Programs:

PGD001 PG Diploma in Clinical Research Associate + GCP Certificate

Our students learn from some of the best faculty in the industry who are certified practitioners with deep experience in clinical trials and monitoring and have a wide knowledge of ICH-GCP, GMP, GLP and HIPAA.
Total Instructional Hours: (800

Course Content- CRA: Instructional Hours (200)

*Drug Approval Process
*Phases of clinical trial and regulatory issues
*GCP/ ICH/ IRB /IEC / HIPAA / CFR/ Source documents/
*Clinical Monitoring/ ICF / Drug Accountability/ AE’s
*Essential Documents in clinical trial
*Investigator /Med DRA/ CRF application
*Study Conduct
*Recruitment, Retention and Compliance

Data Management in Clinical Trial: Instructional Hours (200)

*Data definition, forms & data base design in clinical trials, job description
*Data acquisition, CRF printing ,vendor selection ,CDM presentation at investigator
*Meeting data store, data base validation, data entry and data processing
*Computers in clinical trial, Hardware, operating system ,data management system
*Safety data management , reporting
*Measuring data quality, assuring data quality, data base closure
*Clinical trial patient registration ,Central QC of data in clinical trials
*Software tools for trials management: SAS, ORACLE CLINICAL

Quality Assurance and Regulatory Affairs Program: Instructional Hours (200)

*Day-to-Day operations, pharmaceutical manufacturing, Profile of a research and
*Development (Pre-GMP) company
*Purpose of QA documentation, GLP, Bioresearch monitoring
*GMP documentation/ICH/GMP guidance ,documents
*Overview of Validation, general system and process validation, bulk drug manufacturing
*Validation
*Testing, Documentation for release of materials
*Validation of analytical methods, statistical process control primer and reference tool
*Regulatory affairs, FDA, Rulemaking and adjudication ,product characterization,
*functions of regulatory affairs, Issues in EC, EFTA

Clinical Research Investigator Program: Instructional Hours (200)

*How to get a trial selection and monitoring of clinical investigator
*Clinical Trial investigator
*Phases of clinical trials
*GCP/ICH/IRB/HIPAA
*Recruitment, Retention and compliance
*Clinical trial sponsor,
*Financial disclosure by clinical investigator and other regulatory requirements
*Drug Advertising

Research experience. Students receive extensive hands-on instruction in the methods of the Clinical Research Process as it relates to pharmaceutical and drug manufacturing.

INTERNSHIP

CKTRI provides Internship to the passed out candidates either in India or in USA according to the choice of the candidate. For Internship candidate has to pay charges as given below and no stipend is payable to the candidate during this period.