CDISC & Regulatory Services

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Andronovo offers a range of services to achieve CDISC compliance. Our service offering encompasses both the Clinical Data Management and the SAS Programming aspects of achieving CDISC compliance.

CDISC Strategy, Gap Analysis and Business Case preparation including CDISC compliant tool selection

CDISC Training

SDTM, CDASH and ODM compliant database design services

Data Integration and Data Mapping services for SDTM compliance

Customized ODM Gateway services for external data integration

Legacy CDM conversion to achieve SDTM compliance

SDTM and ADaM compliant dataset preparation

CRT DDS and Define.xml (eCTD) preparation

 

Quality Assurance

 

Quality Assurance includes training and compliance services (audit of investigator sites per-protocol, SOPs, ICH- & CDSCO-GCP and other regulatory requirements).

GCP compliance review

IRB/ EC audits

On-site investigator audits

Drug accountability reviews

Database audit

Study document reviews

Vendor audit

Training Site and Team personnel

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For a quick business enquiry, feel free to contact us.