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CRO Services

HOW CAN WE HELP YOUR CLINICAL TRIAL SUCCEED?

McDougall Scientific is a Contract Research Organization with 30 years of experience specializing in top-tier analytics and reporting of clinical studies. A highly reputed firm, we conduct clinical trials in multiple therapeutic areas and indications and support clinical trials from Phase I to Phase IV, beginning with study feasibility. We provide services to Biotech & Pharma companies, as well as, Investigators and other CROs requiring our expertise. For us, it’s the high repeat and referral client rate that is the best testimony to our proven, nimble approach. 

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Solutions McDougall Scientific Offers

Our clients receive solutions that deliver trial efficiency, always with insights and analytics that set the gold standard in our industry. McDougall designs and manages data collection and analyses for all phases of clinical trials across a majority of therapeutic areas. While the majority of trials target regulatory submission, McDougall supports research for publication and presentation. McDougall has developed the insight necessary to accelerate product development life cycles with adaptive designs and the technology to support business decision-making.

  • Feasibility Assessment
  • Protocol Development
  • Study Startup
  • Medical Writing
  • Phase I-IV Trials
  • Clinical Trial Management
  • Project Management
  • Investigator Initiated Trials
  • Risk-based monitoring
  • Site Monitoring
  • Supply Management
  • Integrated Safety
  • Pharmacokinetics
  • Pharmacovigilance
  • Safety Surveillance

 

 

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Clinical Management System

McDougall’s core services in statistics and data management, both paper-based and Electronic Data Capture(EDC), have established well-defined business processes within the company. All processes are supported by a robust Quality Master Plan, Standard Operating Procedures(SOPs), and a validated computing infrastructure. Our strict adherence to best practices has helped McDougall deliver true business value via a customized comprehensive bundling of services tailored to your trial.

These services can include:

  • Protocol consultation and development
  • Clinical Trial Design and Patient Sample Size optimization
  • Case Report Form (CRF) consultation and development
  • Clinical Data Acquisition Standard Harmonization (CDASH) compliance
  • Trial Risk Management, Planning and Implementation
  • Secure 24/7 study specific Web Portal providing real-time metrics on trial progress
  • Investigator Payment Website calculating and controlling site trial costs 
  • Enrollment Management (via our IVRS/IWRS); minimizes clinical trial costs
  • Randomization & Drug Supply Management
  • ePRO (electronic Patient Reported Outcomes) via our IVRS/IWRS
  • Web-based SAE Report Management
  • CDISC compliant submission level final data sets (e.g. SDTM and ADaM)

 

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Statistical Analysis

McDougall has delivered a tremendous amount of value to it clients over the decades with our relentless insistence of delivering statistical insights clients can trust. Members of McDougall’s statistician team are accredited Professional Statisticians through both the Statistical Society of Canada (SSC) and the American Statistical Association (ASA) averaging over 15 years of progressive experience.

Trusted advisors, our statisticians work during the design phase of a trial or database mining, optimizing sample size, identifying risk factors and recommending strategic analyses such as adaptive designs. The analyses and displays are documented in a robust Statistical Analysis Plan (SAP). 

During project implementation, complex randomizations or robust sampling plans can be executed to support the analysis and interpretation of the data. Analyses can include predictive analytics, simulations, forecasting, and risk detection in support of evidence-based medicine. Data from multiple sources are often integrated and all steps documented producing submission-ready data sets.

Leveraging the teams experience and training McDougall has successfully represented clients with the FDA (USA) & TPD (Canada). McDougall is a Platinum member of the Clinical Data Interchange Standards Consortium (CDISC) and sits on the Advisory Board. CDISC standards (e.g. SDTM and ADaM) are well known and implemented by the statistical team.

 

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Data Management

McDougall Scientific excels at data management, both paper-based formats and Electronic Data Capture (EDC). 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 secure web reporting system allows you to manage site enrollment and activities with 24/7 access and real-time metrics.

The data is captured following CDASH standards, is quality checked and supported by full query management to resolve discrepant issues.  

Medical coding includes MedDRA and WHODD. SAEs can be managed via a safety portal and are fully reconciled prior to database lock. Quality is guided by a protocol specific Data Management Plan (DMP).

McDougall is also a CRO Preferred Partner with Omnicomm Systems; the makers of TrialMaster and TrialOne EDC systems. McDougall has also developed eCRFs and managed data using Sponsors’ EDC systems, giving us valuable experience with at least six other systems. We bundle services and construct a solution to fit your needs.

 

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Document Management

Managing trials in the regulated life sciences means managing documents in a compliant manner. Our expertise in managing your data sets, structured data, carries over to how we manage all your documents and unstructured data to ensure efficient organization, compliance, consistency, and rapid retrieval.

The McDougall document management system follows the full Systems Development Lifecycle to ensure compliance with FDA 21CFR11 and predicate rules, and our computing infrastructure – housed in a Tier 3 collocation facility – is compliant with regulatory requirements and is covered by a comprehensive business continuity plan.

We support clients with multiple needs, including: simple secure document storage; intellectual property (IP) organization; collaborative document authoring; pre-submission organization, where McDougall partners with your regulatory personnel to prepare the information for transfer to their e-submission application; and selected components of the electronic trial master file (eTMF).

Our staff can ensure your suppliers submit reports as per your standard corporate templates, easing the review and integration burden.

 

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Randomization & Drug Supply Management

Randomization & Drug Supply Management at McDougall provides accurate, real-time trial metrics that are available to you 24/7 on your dedicated secure web portal, including enrollment rates and supplies inventory. With up-front training with an online tutorial, customized to your study specifications, we’re able to ensure that your trial runs efficiently from the very start. Our IVRS/IWRS system has a global reach and is eminently flexible.

At McDougall, we have delivered customized applications to meet unique client needs, including:

    • Facilitating adaptive designs including dose escalation
    • Complex randomization allocation and trial supplies management
    • Capturing Patient Reported Outcomes (ePRO)
    • Conducting surveys
  • Recording patient trial status such as reasons for failing screening
  • Executing emergency code break procedures
  • Action based notifications confirming subject randomization

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Applications Development

Technology is a key component to collecting data and disseminating information. McDougall designs, develops, maintains, and supports a variety of technology solutions to efficiently collect data, summarize it, and deliver information to members of project teams who need it, when they need it. McDougall leverages source technology from partners, sponsors’ global licensing, open sources, and in-house licenses, to design a solution to meet your needs within the budget you set.

Most often, this means eCRF (electronic case report form), ePRO (electronic patient reported outcome), and IVR applications (interactive voice response), but may also include custom web applications.

Our team of developers will draw on the breadth of their experience to find the proper solution for you.

Always Quality Results.

“McDougall Scientific is able to analyze requirements and complexities of each project and deliver outstanding, quality results. I would definitely consider using their services for future clinical studies and recommend them to other companies.” -Director, Assay Development Diagnostics

CONTACT

McDougall Scientific

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

McDougall Scientific

Providing over 30 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.

© 2017 McDougall Scientific – 30 years of Clinical Trial Success