Clinical Data Management

What is Clinical Data Management (CDM)?

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.

 

Explore McDougall Scientific’s Clinical Data Management Services

Clinical data quality and integrity are key to clinical trial success. This helps ensure that drug companies deliver reliable data to regulatory bodies and helps guide proper treatment decisions for better patient health. McDougall Scientific provides 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 team of clinical database programmers are well versed in a variety of leading EDC platforms. Our clinical data management team is committed to customizing data solutions that emphasize cost efficiency, data integrity and accuracy. McDougall Scientific is 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. McDougall Scientific’s clinical data management services follow applicable laws and guidelines from regulatory agencies (e.g. ICH GCP and 21CFR Part 11).

Select from our suite of Data Management Solutions:

  • 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

  • SAE Reconciliation
  • Database QA acceptance sampling prior to database lock
  • Data captured using CDASH (Clinical Data Acquisition Standards Harmonization) standards.
  • Follow benchmarks set by SCDMand CDISC.
  • Real-time study metrics viewing and reporting
  • Medical coding (MedDRA & WHODD)
  • SAE Reconciliation
  • Custom Programming
  • Our secure web reporting system allows you to monitor site enrollment and activities with 24/7 access to real-time reports and metrics
  • Database lock
  • Database archival
  • Database transfer

Real-Time Access to Your Data


Our secure web reporting system allows you to monitor site enrollment and activities with 24/7 access to real-time metrics. Data is captured following CDASH (Clinical Data Acquisition Standards Harmonization) standards.

Quality controls are governed by a protocol specific Data Management Plan (DMP), including query management medical coding (MedDRA and WHODD), and SAE reconciliation prior to database lock. The status of your trial data is never is question.

 

Technology Solutions

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, Nextrials, Dacima, Medrio and others.

To learn more about some of the more popular EDC platforms, please visit our EDC Systems page.

Experience matters

When choosing to work with a CRO or a clinical research consulting firm, experience is vital. Even more so with data management being such an essential part of your clinical research. For over 35 years, McDougall Scientific has earned a reputation as one of the most experienced CROs and has been proud to deliver valuable insight and services for clients. 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.

 

Our Approach

Our over 35 years of experience has shown that a consultative and integrated approach is most effective with all our data management clients. We’ll guide you through the critical elements of data management and what impact each has. As well, leveraging our trial design experience with our data management services is the most efficient way to track, clean and manage data for clients. 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. It’s most beneficial to involve the Clinical Data Management team from the beginning of the study. This will ensure a more effective data management plan.

 

Are you looking for ways to enhance your Clinical Data Management?
Choosing McDougall Scientific as your Clinical Data Management Partner would be an effective choice. Industry research shows that pharma and biotech companies are looking to avoid the trap of committing to inflexible contracts from large contract or clinical research organizations. There is a real trend towards working with specialized CROs like McDougall Scientific because of the unique expertise we can provide, the flexibility we can offer and the affordability of our services.

Are McDougall Scientific’s services a good fit for your needs? Contact us to start a discussion around your requirements.


TAKE THE NEXT STEP

Have any questions about your clinical trial design, protocol, or data? Ask our experts for their input or guidance. We are happy to help.

Need ballpark pricing, a comprehensive proposal, an RFP/RFI filled, review of your design, data or your development plan?

Download whitepapers, eGuides, infographics, presentations, articles and other relevant content from our resource center.


CONTACT

McDougall Scientific

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

MCDOUGALL SCIENTIFIC

Providing over 35 years of quality service, McDougall Scientific is one of the most experienced Contract Research Organizations around. We look forward to speaking with you about your Clinical Trial needs.