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
- 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
- Process and analyze data collected from the Clinical Trial (pharmaceuticals, biologics, or devices).
- Coordinate the receipt and processing of information for projects (e.g., coding dictionaries)
- Electronic data capture.
- Ensure databases are validated and ready for transfer and/or analyses.
- Provide Clinical data management support to Clinical Operations team and/or study project.
- Provide Clinical data management support Clinical Data Management team and Biostatistics team.
- Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports).
- Develop Data Management Plan (DMP), maintains DMP throughout life-cycle of study project.
- Ensures DMP is followed according to study design and requirements.
- Develop Case Report Form (CRF), electronic and/or paper.
- Develop database (DB) clinical trial data specifications, including eCRF design, user requirements.
- Edit rules/checks, query logic and data validations.
- Lead EDC database (DB) specification process
- Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Reconcile electronic data transfers from vendor to Sponsor.
- Develop test scripts and execution logs for User Acceptance Testing (UAT).
- Coordinate UAT of eCRF build and validation documents.
- Edit check document, issue logs, UAT summary report.
- Maintain/track EDC user management and other Clinical databases across allocated Clinical trials.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical
- Review, interim review, and or final database lock, data reconciliation and/or coding.
- Assist in defining and/or create data listings, summary table validation, data specifications and/or process
- Transfer data in preparation for statistical review and/or data management audit.
- Coordinate the archiving of study databases and related documents.
- Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
- Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB,
- Including but not limited to, performing MedDRA and/or WHO coding.
- Assist and provide input into study and project level data analysis plan.
- Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests
- Plan projects, and/or eCRF development activities.
- Collaborate with IT and implementation team(s) to address Clinical application requests
- Collaborate with IT and implementation team(s) to address changes to Clinical database systems.
- Participate in the preparation and presentation of data, when applicable.
- Ensure data system compliance by following the established guidelines of regulatory authorities.
- Creation of SDTM annotated CRF
- Creation of Database Structure Document
- Creation of Edit Check Specification Documents
- Study User Acceptance Test (UAT) documents
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.
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.
Gratisol Labs Clinical Data Management certification course is recognized internationally in all the countries that are signatories to the ICH-GCP guidelines for clinical trials. This includes USA, Canada, India, EU countries, Czech Republic, Singapore, South Africa and many others.
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
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 firstname.lastname@example.org