Clinical Data Management Services

Data Management - icon

What is Clinical Data Management?

Clinical data management (CDM) is an essential part in the data collection phase of clinical research. CDM ensures collection, integration and availability of data, hopefully leading to high-quality, reliable, and statistically sound data from clinical trials. The process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free. The ultimate goal of CDM is to ensure that conclusions drawn from research are well supported by the data. Ultimately, Drug developers want to ensure that the data delivered to regulatory bodies is reliable and that clinical data captured guides proper treatment decisions, which impact patient health.

Our Clinical Data Management Services

We provide dedicated clinical data management services from database build to database lock and archiving. Our method to capture, manage, clean and deliver data is efficient and scalable.

We offer a full suite of services utilizing traditional paper-based solutions and/or electronic data capture (EDC) solutions.

Our clinical data management team is committed to customizing data solutions that emphasize cost efficiency, data integrity and accuracy.


  • Consulting (strategic program planning, protocol review, etc.)
  • EDC consultation, design, selection
  • Data capture and management using multiple EDC systems
  • Paper setup and management
  • Data Management Plan (DMP)
  • Database build, design and implementation
  • Data validation, review, cleaning, quality control
  • Data processing through double data entry
  • CRF/eCRF design and development


  • CRF Annotation & Review
  • Edit checks Programming & Testing
  • Query Management
  • Support for Safety Monitoring
  • Database QA acceptance sampling prior to database lock
  • Data captured using CDASH (Clinical Data Acquisition Standards Harmonization) standards.
  • Follow benchmarks set by SCDM and CDISC.



  • Real-time study metrics viewing and reporting
  • Medical coding (MedDRA & WHODD)
  • SAE Reconciliation
  • Custom Programming
  • Database lock
  • Database archival
  • Database transfer

Clinical Data Interchange (CDISC) - logoWe are a CDISC Platinum Solutions Provider , our team of Clinical Data Managers are certified by the Society for Clinical Data Management (SCDM) and are supported by compliance-driven Standard Operating Procedures. Our services follow applicable laws and guidelines from regulatory agencies (e.g. ICH GCP and 21CFR Part 11)

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Our Service Approach

Over 40 years of experience has shown that a consultative and integrated approach is most effective with our data management clients.

  • We’ll guide you through the critical elements of data management and what impact each has.
  • Leveraging our trial design experience with our data management services is the most efficient way to track, clean and manage data for clients.
  • It’s most beneficial to involve the Clinical Data Management team from the beginning of the study. Establishing reliable, accurate and quality clinical data is not an activity only done after the data is collected. Rather, the process starts before the study protocol is finalized. This will ensure a more effective data management plan.

EDC

We leverage industry-leading technologies to provide the most efficient solutions for your study. We work with our client’s existing technologies or, if required, are ready to provide recommendations on which technology platforms would best suit client requirements. Some of the EDC platforms we have already worked with or evaluated include Omnicomm TrialMaster, OpenClinica, Trialstat, Medidata-Rave, Dacima, Medrio and others. 

Our Team

Our team’s credentials and tight adherence to processes makes us one of the easiest and effective teams to work with. Our core team is comprised of long-standing and eminently qualified analysts, statisticians, clinical data managers, application developers, and project managers. Their years of industry experience allow them to mitigate the many risks inherent in clinical research for our clients.

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CONTACT

Alimentiv Statistics

789 Don Mills Road, Suite 802, Toronto, Ontario M3C 1T5 Canada
Phone: (416) 424-2092

ALIMENTIV STATISTICS

Providing 40 years of service, Alimentiv Statistics is a niche Contract Research Organization focused on Biostatistics, Statistical Analysis, Clinical Trial Design and Data Management. We invite you to see how we exceed our clients’ expectations.