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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.
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
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