Services for Clinical Trials

CLINICAL INSIGHT & ANALYTICS THAT SET THE GOLD STANDARD IN OUR INDUSTRY.

McDougall Scientific is a Contract Research Organization with 35 years of experience specializing in top-tier data management, analytics and reporting of clinical studies. A highly reputed firm in multiple therapeutic areas and indications supporting clinical trials from Phase I to Phase IV. 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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OUR PRIMARY SERVICES

Our work is driven by a relentless insistence on insights clients can trust.

 

STATISTICAL ADVISORY & CONSULTING

The way your team plans, collects, manages, controls, analyzes, interprets and prepares clinical data can significantly impact the success of your trial. McDougall Scientific brings over 35 years of experience that will help deliver objective perspective to clients. We offer statistical consultancy in areas such as Protocol design & review, sample size calculations, statistical methodologies, Bayesian analysis, data quality oversight, development of protocols and Statistical Analysis Plans (SAPs), among other areas.

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STATISTICAL PROGRAMMING & ANALYSES

Members of McDougall’s statistician team are accredited Professional Statisticians through both the Statistical Society of Canada (SSC) and the American Statistical Association (ASA). Having such a breadth of experience among our statistical team enables us to provide clients with services that make a real impact. 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. Our statisticians ensure your objectives are clearly articulated in the protocol and supported by an efficient design, appropriately captured data, and pre-specified analyses.   

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CLINICAL TRIAL DESIGN

Clinical trial design is a critical step in implementing a successful clinical research program. McDougall Scientific’s over 35 years of experience will help in providing you with a 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.  

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CLINICAL DATA MANAGEMENT

McDougall Scientific provides dedicated clinical data management services from database build to database lock and archiving. Our clinical data management team is committed to customizing data solutions that emphasize cost efficiency, data integrity and accuracy. 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. 

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SUPPORTING SERVICES

Our 35 years of industry experience helps provide you with a more complete range of services.

 

Real World Evidence Services- Post Marketing Observational Studies (PMOS)

Whether you are planning Health Economics & Outcomes Research (HEOR), a post-marketing observation study, a safety surveillance system, a chart review, or are augmenting a randomized controlled trial (RCT) with Real World Data (RWD), McDougall will align your data collection and analyses with your objectives. Tap into McDougall’s statistical expertise to mitigate the risks inherent with messy Real World Data.
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EDC Services – consultation, design, and development

McDougall has developed eCRFs using numerous EDC platforms and supported development on additional platforms. If you have not selected a platform, we will help you choose one that fits your requirements and budget. McDougall follows a system development life cycle to ensure your application supports the protocol, is 21CFR part 11 compliant, and undergoes comprehensive user acceptance.
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Protocol Development, including sample size optimization

McDougall medical writers and statisticians have taken many studies from concept to final protocol. Our statisticians collaborate with KOLs and SMEs to formulate clear and concise study objectives and endpoints. We provide innovative design options to maximize each participant’s information towards your objectives. Our aim is to design your study to answer research questions with high confidence while meeting regulatory requirements subject to business constraints.
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Paper Case Report Form (CRF) consultation and development

In this age of electronic data capture, paper-based methods continue to play a role. There is no need to incur the development costs of EDC for small studies. ePRO can also be a challenge in some patient populations. Electronic and paper data collection differ by question ordering, skip patterns, repeat methods, quality assurance techniques, and other characteristics. With 35 years of experience collecting and managing data, McDougall is well-suited to develop your paper CRF to support your protocol.
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Medical coding –

MedDRA, WHODD

By abstracting and coding key data fields from clinical trials by trained coders using approved coding tools e.g. Adverse Events (AEs) using MedDRA (Medical Dictionary for Regulatory Activities) and Concomitant Medications (ConMeds) using WHO-DD (WHO Drug Dictionary), your trial data meets the reporting requirements for Regulatory agencies internationally, and is easily combined for integrated safety summaries. Make it a point to speak with a McDougall Scientific expert concerning your Medical coding needs.
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Medical writing, editing & 

Publishing

Medical writing requires well-structured documents with clear and concise information. McDougall Scientific has the skills necessary to deliver full-service medical writing, editing, and electronic publishing of regulatory documents and scientific publications such as clinical study protocols, regulatory submission documents, Investigator’s brochures, patient safety narratives, Statistical reports, selected eCTD modules, Study reports, safety reports, clinical summaries of efficacy and safety, Research proposals among others.
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Automated patient

narratives

Automating patient narratives can reduce production time and cost by up to 80%. Why pay high-valued medical advisors for typing. Using your narrative template, McDougall’s automated process writes each narrative from select SDTM data. A medical advisor then needs to only “humanize” the automated text and add an interpretation. Speak with a McDougall Scientific expert concerning your Automated patient narrative requirements.
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Pharmacokinetics &

Pharmacodynamics

An essential part of your drug development plan is to establish that your compound is safe and effective. Well-designed Pharmacokinetic trials (which determine how the body affects the drug) measuring plasma levels of varying doses across time, provide you with the knowledge to plan well-controlled later phase trials with different doses, or dosing regimens, to evaluate how the drug affects the body (Pharmacodynamics) and establish safety and efficacy.
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Trial Risk Management, Planning and Implementation

If you are conducting a post-mortem, then it is too late. It is better to conduct a pre-mortem to identify risks to the success of your study. McDougall data managers and statisticians will collaborate with your study team to identify risks related to recruitment, data capture complexity, endpoint suitability, statistical power, population variability, and so forth. McDougall will suggest CRF designs, study designs, or monitoring reports to minimize risks. Ongoing analytics can be used to adapt risk-based monitoring decisions as the study progresses to improve and maintain study integrity.
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Automated Investigator

Payments

McDougall developed its first automated investigator payment system in 2007 to help a customer who was struggling to calculate accurate investigator payments. Since then, McDougall’s protocol-specific automated payment system has saved clients’ countless hours and dollars calculating payments and lost money due to inaccurate payments. Our programmers will customize payment calculations to your protocol’s event schedule and site fee schedules. We can include hold-back and reconciliation capabilities and will generate a letter and detailed list of fees to accompany each payment.
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Randomization and Clinical Trial Supply Management – ( IVRS/IWRS)

Although many EDC systems include a randomization engine, they often lack flexibility and scalability. McDougall’s IWRS has yet to run into a study design so complex that it could not be programmed. Study supply shipments from depots can be centralized or decentralized. Supply expiry or damage is recorded to remove supplies from availability. Shipments can even be transferred from site to site in emergencies. Notifications and alerts are customized for your study team and needs. Data that are entered for randomization is transferred to your eCRF to avoid duplicate manual entry. Don’t change your study design or protocol due to technology limitations. Speak with McDougall first.
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CDISC data standards:

SDTM and ADaM

SDTM and ADaM datasets are essential in your submission for approval. The study data tabulation model (SDTM) defines the way in which individual observations from a clinical study are compiled and provides standards for organizing clinical trial data following database lock. The analysis data model (ADaM) specifies the fundamental principles and standards to ensure that there is clear lineage from data collection to analysis and provides a connection between the SDTM data sets and final statistical analyses. McDougall Scientific has been collecting and analyzing data for over 35 years. Speak with us about CDISC standards.
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Integrated Summary of Safety & Integrated summary of Effectiveness (ISS & ISE)

ISS & ISE summaries are more of an analysis of results that determine the safety and effectiveness of drugs in development. The results from all clinical trials performed on the drug are brought together and analysed as a whole, producing combined statistical results. The ISS summarizes safety based on data collected from all clinical trials related to the product and is considered one of the most important documents in a New Drug Application (NDA), and is typically required by regulators. McDougall Scientific statistical experts can help with your ISS & ISE requirements.
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Independent Sponsor and

CRO Oversight

The newly release GCPs -i.e. Good Clinical Practice or ICH E6(R2), adds the additional Sponsor requirement under section 5.2.2 that, “The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).” Our trained statisticians and data managers will work with you and your company to plan the CRO oversight obligations, and perform the agreed to tasks following the plan, to ensure your duty is effectively discharged.
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Electronic Trial Master File

(eTMF) Solution

Managing clinical trial documents through paper-based or network-folder TMFs can be time-consuming and may produce costly errors that put your clinical trials at risk. Adopting an eTMF allows for shorter trial start-up and close-out times, cost savings and real-time oversight and management of documents to ensure compliance and audit readiness. McDougall Scientific provides the industry with its own eTMF solution and manages your trial documents with the same sophistication as it manages your data.
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Clinical Technology

Consulting Services

We provide consulting to solve technology issues you may be facing around your trial needs. 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. We provide consulting on programming, integration, IVR, EDC, eTMFs or Drug Supply Management. McDougall’s proficiency in the industry’s top technologies will help make your clinical process more efficient.
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Training & Development: Statistics for Clinical Research Professionals

McDougall Scientific produces custom training courses on Statistics for Clinical Research Professionals. This course covers protocol development, overall design concepts, analysis planning, data requirements, designing the study, interpreting results and statistical methods. The primary focus is to provide an understanding of the key statistical components required and for individuals to be able to demonstrate competencies in these components and apply them to clinical trials.
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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.

Exceeding expectations for over 35 years.

“McDougall’s commitment to quality is reflected in their stellar data management processes and statistical analysis. I look forward to having the opportunity to work with McDougall again.” -Clinical Research Manager, Biopharmaceutical Company

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.