Clinical Data Management Expertise

Anovus Clinical Research understands that the client needs a supporting hand for enhancing the speed of the trial; managing the pouring data from the trials and streamlining it to make it available for analysis. Addressing the challenge of handling robust, varied and high quality data by controlling the cost on the same hand, we extend our services in data management by bringing together the best team on to the field and also ensure quality and regulatory compliant services. Our team has the best knowledge on CDISC guidelines, ICH-GCP, applicable regulatory guidelines and standard clinical data management systems.

Anovus fosters efficiency right from building the database to database lock.

Service offered :

Database Design, Development & Deployment
Data Extraction, Database Lock, Closeout and Delivery
Data Conversion to any Sponsor's Data Specifications
CRF/eCRF Design, Production and Review
CRF Annotation and Completion Guidelines
CRF Log and Tracking
Develop and Manage Data Management and Submission Plans
Single Data Entry/Double Data Entry and Source Data Validation / Verification
Query Management
Interim Analysis Readiness
Knowledge and make use of current Data Standards (SDTM, CDASH, and other CDISC models)
Medical Coding (Adverse Events, Medication and Laboratory)
Serious Adverse Event (SAE) Reconciliation
Customized status reporting and generation of Data Listings

Site Management    Medical Writing    CDM   Statistical Analysis    Pharmacovigilance   CDISC   Regulatory Affairs

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