Clinical Data Management Services (CDM)

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Clinical Data Management Services (CDM)

ClinData provides a complete range of data management services. Our CRF/databases are designed to meet the needs of clients. We also provide Consultation Services by our CDM certified professional consultants in data management dedicated to the pharmaceutical, biotechnology, medical device, and clinical research industries in this region. ClinData provide solutions that include software and services that allow clients/ sponsors to achieve clinical results by streamlining the capture and management of clinical study data

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Further, it provides professional services that are customizable to client requirements, cost effective, including implementation services to meet clients’ data requirements for various indications; workflow design to meet the needs of various study phases, secure and regulatory -compliant requirements; and based on guidance on best practices.

ClinData services and systems are governed by well defined SOPs and are compliant with regulatory requirements such as ICH/GCP, FDA 21 CFR Part 11 and other sponsor specific standards.

The team has extensive data management experience across a broad range of therapeutic areas, using both paper and EDC systems.

It is intended to be a comprehensive and detailed description of Clinical Data Management (CDM) procedures during a conduct of a study in accordance with applicable CDM SOP, international quality standards, professional guidelines and regulatory requirements.
A CRF is a formatted listing of data elements that can be presented in paper or electronic formats.

More importantly, a CRF is a representation of the patient-level fields and data entry options in the registry database; it could also be described as the database requirements.

It defines the type of data collected and amount of data collected, therefore CRF is a critical piece of the study.
CDM create annotated CRFs with an extensive set of metadata information (e.g., question name, SAS name, CRF name) and as a separate PDF file.
Our clinical data management system (CDMS) is 21 CFR Part 11 compliant that provides comprehensive audit trail report and with comprehensive security administration. CDMS fully support industry standards and provides a built-in library of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM).

The data management system is part of a validated system that complies with Good Clinical Practice (GCP) predicate rule requirements, laws and regulations for clinical trial conduct, and FDA 21 CFR 11 compliance for electronic record and signature use.

Database design and development is based on database design specifications, data definition document and Edit Checks Specification also known as data validation manual that contains all the programmable and non programmable data checks specified by the sponsor or the protocol.
It is constantly validated per study / database set up to ensure that the system is performing consistently according to the SOPs, URS and any other applicable guidelines. The validation process during system operational use include:

  • User training
  • User support
  • System administration and maintenance
  • Change control
If paper is the preferred choice for the study, ClinData Consult offers tracking of data collection using paper CRF and data entry services. We adopt double data entry data capture methods with a third person to resolve any discrepancies between first and second entry.

ClinData Consult also provide value added services for paper based study which includes logging of CRFs for tracking (to trace and track) every transmission and receipt of CRF from study site & scanning of CRFs as electronic backup copies via in-house built application.
Any potential problem/error with the data identified in the course of data processing and cleaning as per edit checks specification and data handling convention that requires a data query to be raised to the investigational site is accomplished by means of Data Clarification Form (DCF). Every single DCF (including CRF) is tracked via in house built application. Electronic queries for EDC studies are raised, tracked and managed resolved.
We provide auto-coding to code adverse events, diseases or drugs. Adverse event, medical history verbatim terms and any other relevant data as specified in Coding Specification Document are coded using Medical Dictionary for Regulatory Activities (MedDRA). On the other hand, Prior and Concomitant Medication verbatim terms are using WHODRUG. Clients or sponsors are required to review and approve the codes assigned before database lock.
Perform SAE reconciliation with the pharmacovigilance team.
Data QC process that involves periodic review of the data including DCF, tracking and filing of CRF and DCF, data entry errors and data management procedures; and Data entry vs. original paper CRFs.
Database lock is an important milestone for a study and data management team in ClinData Consult.
Develop detailed CRF tracking report, including the identification of missing and late case report forms (CRFs). It has an extensive list to ensure that all steps as listed in the SOP are complete, a documented approval process take place, with sign-off by Authorized study personnel. Once approvals have been obtained, edit access to the database will be removed and the date documented.