Clinical Data Management Training @ Gratisol Labs

Gratisol Labs is a leading resource consulting services organization for the Pharmaceutical, Biotechnology and Medical Device industries. We offer contract and permanent job opportunities within the Pharmaceutical, Biotechnology and Medical Device industries to both experienced professionals and entry level candidates.
The services offered fall into the broad categories of Recruitment Solutions, Temporary Staffing, Outsourcing, Consulting, Training in Clinical Data Management, Pharmacovigilance,CDISC SDTM & SAS to aspirants of Clinical Research Industry. We successfully help some of the top Pharmaceutical, Biotechnology and Medical Device organizations from around the world to recruit high caliber experienced & trained professionals.
The Pharmaceutical & Clinical Research Industry, worldwide is facing a huge shortage of trained manpower resources. With a View to fill this gap between the demand & supply of trained manpower and to help Pharmaceutical & Clinical Research industry to move on the fast track Gratisol Labs offers cutting-edge packaged and customized corporate training programs. In addition, Gratisol Labs has developed a tailored training division ‘Gratisol Academy of Clinical Research’ to provide Training, Internships, & Educational programmes that are designed to develop careers for clinical research professionals in Clinical Data Management, Pharmacovigilance & SAS.

We have the global capabilities and a flexible approach to meet our clients’ needs. Our operational excellence brings quality, efficiency and effectiveness to operational performance. The services offered fall into the broad categories of temporary staffing, permanent placement, outsourcing, consulting and outplacement. We successfully help some of the top scientific, clinical, biotechnology and pharmaceutical organizations from around the world to recruit high caliber experienced professionals.

Through our vast nationwide network and “talent sourcing” model we are able to rapidly respond to our clients with excellent results and personalized customer service, making us one of the most innovative and reliable healthcare staffing and search firms.

Gratisol Labs also provides Site Management Services, Clinical Data Management, Pharmacovigilance, Medical Writing, Biostatistical Analysis, SAS Programming & IT Support Services to Pharmaceutical, Biotechnology and Medical Device Organizations globally.
The focus of the lectures will be mainly on the following topics:
• Introduction to Clinical Research & Clinical Data Management
• Fundamentals of Clinical Research &Roles in a CRO
• Clinical Data Management Process and Life cycle.
• ICH – GCP guidelines
• Protocol Designing
• CRF /e CRF Designing
• CRF Annotation
• SOP Preparation (Standard Operating Procedure)
• CDISC STANDARADS
• Preparation of essential documents in CDM process (Data Management Plan ,Database Structure Document, Edit Check Specification document, Study User Acceptance Test(UAT)
• Database Design
• Data Validation programming and standards
• Database testing
• Data entry
• Discrepancy Management
• DCF Management
• Electronic Data Capture and Remote Data Capture.
• Management of Medical Dictionaries(MeDDra, WhoDD)
• Query management(DCF management) Coding
• External data managing (e, g: Lab data, ECG, BMD etc.)
• Clean Patient Delivery
• Database Lock, Freeze.
• SAS data Extracts
Mode of training- Instructor Led Class room/ Online Training
Practical Training will be also provided on the following topics:
• eCRF Design
• Data Entry
• Discrepancy Management
• Batch Validation