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Clinical Data Management Program - Gratisol Labs

Clinical Data Management Certification Program

Effective clinical data management (CDM) is at the core of any successful clinical trial. At Gratisol Labs, we’ve made the collection and handling of clinical trial data a central part of our entire service offering. Gratisol Labs CDM team leaders have more than 12 years of experience, on average, and a background in medicine or biological sciences. Each has experience in multiple therapeutic areas and in handling data needs for local, regional and global trials.

CDM services are available as part of our integrated service offering or under a complete or partial Functional Service Provider (FSP) relationship. Our global staff uses our well-documented processes and service levels agreements to ensure timely deliverables. We handle all phases of clinical research across the full spectrum of therapeutic areas.

Our Team has many years of Industry experience working with clinical data management systems as well as working on our customers’ systems provided by other vendors. Gratisol Labs can provide complete data management for your project or individual services as needed:

  • CRF page tracking
  • CRF design
  • Database design and programming
  • Integration of data from other sources
  • Coding
  • Data validation
  • Status and tracking reports
  • Patient related outcomes
  • SAE reconciliation
  • Electronic Data Capture
  • Paper CRF studies
  • Double data entry
  • Data coding and cleaning
  • Validated electronic edit checks
  • Support for EDC and Paper CRF’s
  • Creating SAS Data extracts

Advanced Certified Program In Clinical Data Management 

Clinical Data Management is a branch of Clinical Research concerned with managing and processing the data gathered during clinical trials.  Clinical Data Management (CDM) is recognized as the crux of Drug Development process. It satisfies the specialized needs of the critically important Drug Development in terms of quality, accuracy, verifiability, consistency and above all, conformity to local regulations, and GCP. CDM plays a vital role in Drug Development and Clinical Trials. It assures integrity & quality of data being transformed from trial CRF to database system. The course comprises theory and practical sessions, case study assignments, and exercises. During all practical sessions, the students will get hands-on experience on Clinical Data Management software and its applications. 

This course will provide extensive training in the niche domain of clinical data management.  It incorporates end-to-end theoretical & practical training sessions on Clinical Data Management applications widely used by Pharma & IT Industry.

Following Course Content will be covered during the training:

  • Welcome and Introduction to Clinical Data Management
  • Drug Development and Clinical Trial Phases 
  • Fundamentals of Clinical Research & Roles in a CRO 
  • Clinical Data Management Process & Life cycle
  • ICH – GCP guidelines
  • GCDMP guidelines 
  • Paper Vs Electronic Data capture 
  • Data Management Plan document
  • Introduction to CDISC SDTM  Standards 
  • Application of SDTM Standards.
  • Clinical Study Documentations Setup
  • CRF Annotation
  • Creation of SDTM annotated CRF 
  • Creation of Database Structure Document 
  • Creation of Edit Check Specification Documents 
  • Study User Acceptance Test (UAT) documents
  • Project Initiation
  • CRF Design/ eCRF design 
  • 21 CFR Part 11 Regulations
  • Questions and Discussions

ELIGIBILITY:

Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:

Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) and all professionals working with Pharmaceutical companies, CROs and Hospital.      

SELECTION PROCEDURE:

To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:

  • Personal Interview 
  • Screening And Selection Of Students

GRATISOL LABS ADVANTAGE:

  • Complete Course Material will be provided including detailed information about the entire work flow of Clinical Data Management. 
  • 2 months internship available after rigorous training in Clinical Data Management.
  • Own CRO live Projects 
  • We Provide Real Time Experience on Clinical Data Management Software with eCRF designing.
  • Highest Placement record across all training institutes 
  • Industry based SOP’s  training 
  • Trainers with minimum of 7+ years of experience 
  • Comprehensive teaching by Medical Doctors 
  • Hands on experience on Clinical Data Management Software’s used in the Industry. 
  • Total 200 hours of exposure to theory, case studies and practicals.
  • Practical training will be provided on eCRF designing, Data Entry, Discrepancy Management, Batch Validation, MedDRA Coding.

OUR TEAM OF EXPERIENCED CLINICAL DATA SPECIALISTS ALSO PROVIDES THE FOLLOWING UPON SUCCESSFUL COMPLETION OF TRAINING:

  • Resume Preparation 
  • Interview Preparation with real time questions and answers
  • Mock Interview Sessions
  • Communication Skills and Personality development Sessions
  • Placement Assistance
  • Placement Assurance

Certification:

Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.

A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry. 

For more information, please contact Gratisol Labs at info@gratisol.com

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