Clinical Records Management Services

Records and information management (RIM) methodology, Support during Record creation, Record maintenance and regular reviews etc.

TMF - Trial Master File

Maintain and store documents, images and content related to the clinical trial in TMF, Evaluate and manage essential documents for GCP compliance and standards etc.

eTMF - Electronic Trial Master File

Subject to regulatory controls specified under FDA Title 21 CFR Part 11, Limit system access to authorized individuals etc.

Records Management

Document IT maintains the records and documents throughout their life cycle from the time they are created until their disposal. This process includes identifying, classifying, storing, securing, retrieving, tracking and destroying or permanently preserving records. Document IT consultants have acquired a practical understanding of how documents and the contained information can provide evidence for the regulated activities of the investigator, the sponsor, and the IRB/IEC.

Clinical Records Management Services

  • Records and information management (RIM) methodology
  • Support during Record creation
  • Record maintenance and regular reviews
  • Access and disclosure of records
  • Archiving
  • Disposal or archival preservation
  • Control and safeguard the information assets of the entity
  • Address security, privacy, disaster recovery, emerging technologies, and mergers
  • Specify regulatory requirements and business expectations for source data

Document IT
Document IT

TMF - Trial Master File

  • Maintain and store documents, images and content related to the clinical trial in TMF
  • Evaluate and manage essential documents for GCP compliance and standards
  • Permit evaluation of the conduct of a trial
  • Permit evaluation of the quality of data produced
  • Contingency planning strategy for source document deficiencies
  • Communicate and manage site and sponsor activities regarding electronic health records
  • Apply best practices and validate automatic workflow configurations for essential document review and handling

eTMF - Electronic Trial Master File

  • Subject to regulatory controls specified under FDA Title 21 CFR Part 11
  • Limit system access to authorized individuals
  • Operational system checks
  • Authority checks
  • Device checks
  • Determine that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
  • Establish and adhere to written policies that hold individuals accountable for actions initiated under their electronic signatures
  • Appropriate controls over systems documentation
  • Electronic signatures
  • Record Audit trail (timestamping of records)
  • Record export to a portable format such as PDF or XML
  • Metadata applied to documents is recommended be formally defined to ensure consistency across all documents

Document IT

Project
Management

Our experienced Project Managers can plan, organize, motivate and control your resources to achieve your specific goal(s).

Quality
Management

For more than 15 years Document IT & its partners have been at the forefront of computerized system validation & IT system compliance.

Quality Management

Business
Consulting

Our consultants work with clients to model & improve business processes, streamline operations & assure compliance.

Business Consulting

Resourcing
Services

Our resourcing services are open to any industry looking for a highly skilled worker.

Outsourcing

We currently offer full business process outsourcing within our CDISC Factory for clinical business processes around the usage of standardized clinical data.

Outsourcing

Bio Statistics

Our expertise includes the design & conduct of clinical experiments, the method & way in which data is collected, analysis of data & interpretation of results.

Clinical
Programming

We offer you comprehensive range of high-quality & cost-effective clinical programming services.

Clinical Programming

Clinical Data
Management

We provide end to end clinical data management solutions from data management plan to database lock.

Clinical Data Management

CDISC
Factory

Document IT’s CDISC factory supports & accelerates the set-up of CDISC compliant systems & conversions of legacy clinical trial data to the CDISC standards.

Records
Management

Document IT maintains the records & documents throughout their life cycle from the time they are created until their disposal.

Records Management
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