Clinical Trial Design

Investing in your Trial Design maximizes your investment.

Poor trial design or planning is the main cause of issues or errors occurring in clinical trials. No amount of statistical methods can rescue poor trial design.

 

The design of the Clinical Trial is a critical step in implementing a successful clinical research program. Investing in clinical trial design enables you to maximize the value of your overall investment. McDougall Scientific’s over 35 years of experience will help in providing tailored clinical trial design specific to your research goals. We can recommend appropriate trial designs ranging from simple single end point designs to more sophisticated Bayesian adaptive designs.

We’ll develop clinical study plans and protocols and provide the knowledge and support that is required to best address your specific business goals. Not only do we leverage our extensive experience, track record and current insight to design your protocol but we use a collaborative approach to clinical trial design that helps us define challenges, opportunities, data sets, assumptions, benefits, risks and validations for your team.

The depth of experience from our team of experts will help you realize the full potential of your protocol.

 

UNLEASH YOUR TRIAL DESIGN

The objective of clinical trials is to establish the effect of an intervention. There are many aspects that must be considered when designing clinical trials; the first is being able to clearly define a primary clinical research question. Other fundamental issues include minimizing variation, randomization and stratification, blinding, placebos, selection of a control group, selection of the target population, the selection of endpoints, sample size, and planning for interim analyses among others.

 

There are many issues to consider when designing a clinical trial and our trial design experts will design your study to answer your research questions with high confidence. Some of the design services we provide include:

Sample Services:

  • Statistical and analysis planning
  • Clinical consultation
  • Statistical sample size calculation
  • Endpoint selection and confirmation
  • Resource planning
  • Protocol writing
  • Protocol review

  • Randomization scheduling
  • Cost estimation
  • Case report form (CRF) design
  • Literature review
  • Regulatory consulting

ADAPTIVE CLINICAL TRIAL DESIGN

An approach to clinical trials popularized in the mid 1990’s, Adaptive-By- Design allows for adjustments and modifications during the clinical trial, making the study responsive in real-time. Increasingly popular, Adaptive design helps sponsors determine if the therapy is going to fail, and if so, to help it fail early, shortening timelines and reducing costs.

Adaptive trials help expedite and improve efficiencies and increase a trial’s probability of success.

To learn more about McDougall Scientific’s Adaptive by Design services, please visit the Adaptive Clinical Trial Design page.

WORKING WITH McDOUGALL SCIENTIFIC

Are you looking for ways to enhance your trial design, your statistical analysis, data management or overcome challenges in your clinical trial?

McDougall Scientific brings over 35 years of experience that will help deliver objective perspective to clients. We offer services in areas such as Protocol design & review, statistical methodologies, Statistical Analysis Plans (SAPs), Bayesian analysis, sample size calculations, data management, data quality oversight, among other areas.

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.