Research

Thinking of hiring a contract research organization with a social purpose?

You’ve come to the right place.

We support community-based studies and multi-centre clinical trials alike—bridging science and systems change with research initiatives across North America.

 We do both

Two pathways. One purpose: better evidence for better systems.

Explore Clinical Trials
Explore Applied + Community Research

We set up your research project for success from Day One.

Clinical Trials

As one of North America’s only social purpose Contract Research Organizations, we help sponsors, research teams, and patient communities move from concept to close-out with confidence. Our clinical trial services cover it all - from protocol development, regulatory strategy, and ethics submissions to data systems, and quality oversight – grounded in Good Clinical Practice (GCP) and equity-centred, decolonizing research principles. Whether you’re piloting feasibility, navigating Health Canada or FDA requirements, or preparing a multi-site trial, we design studies that are implementable, compliant, and inclusive.

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  • Systematic reviews form the foundation for high-quality clinical research. By rigorously synthesizing existing evidence, we help sponsors and investigators refine research questions, select outcomes, and justify new trials. Our reviews identify knowledge gaps, strengthen scientific validity, and ensure each study builds on the strongest possible evidence base.

  • Every successful trial or study starts with a rigorous, evidence-based, and inclusive design. We build research protocols and operational procedures that are implementable, compliant and strategic, supporting the pathway from idea to implementation and approval.

  • Navigate Health Canada, FDA, and REB/IRB submissions with clarity and confidence. We prepare study documents, consent forms, and regulatory strategies that uphold participant safety and respect Indigenous data sovereignty and OCAP® principles.

  • Effective project management keeps trials moving forward on time, on budget, and in full compliance. Our project managers coordinate cross-functional teams, manage timelines and deliverables, and act as the central point of accountability between sponsors, investigators, regulators, and the rest of the research team. With a focus on collaboration, quality, and GCP alignment, we ensure each study runs smoothly from initiation to close-out.

  • Good data starts with smart and compliant systems. We build electronic data capture (eDC) platforms, case report forms, manuals, and data plans that meet GCP, Good Data Management, and ISO standards, ensuring accuracy, traceability, and scientific integrity. 

  • We develop tailored Quality Management Systems, SOPs, and risk-based monitoring plans that improve oversight, strengthen compliance, and ensure regulatory readiness without adding unnecessary burden to sites or staff.

  • Our CMC experts ensure investigational and commercial products meet the highest standards of safety, quality, and regulatory compliance. From formulation and process development to scale-up, validation, and submission, we bridge scientific, operational, and regulatory teams to maintain GMP integrity and streamline development timelines.

  • Our biostatisticians design scientifically valid studies, determine sample sizes, and develop statistical analysis plans that ensure rigour and reproducibility. Working closely with clinical, regulatory, and data teams, they analyze and interpret data to deliver clear, evidence-based insights that support decision-making and regulatory submissions.

  • Clear, compliant, and compelling communication is critical to every stage of a trial. Our medical writers produce high-quality scientific and regulatory documents, including manuscripts, clinical study reports, new drug applications, medical illustrations, and clinical guidance documents. We translate complex data into precise, accessible content that meets regulatory expectations and strengthens scientific credibility.

  • We deliver hands-on training for site staff and partners on documentation, GCP compliance, participant engagement, cultural safety, and anti-racism, building the practical and ethical skills needed to run inclusive, high-quality trials.

  • We facilitate authentic engagement with participants, communities, and partners through advisory boards, co-design, and governance structures that build trust, transparency, and accountability throughout the research process.

  • From plain-language summaries to dashboards, manuscripts, and funder briefs, we transform trial findings into accessible insights that drive policy, inform practice, and advance health equity.

Applied + Community Research

Our Applied and Community Research practice focuses on generating high-quality evidence in real-world settings. We design and conduct behavioural RCTs, cohort and longitudinal studies, literature and systematic reviews, and qualitative or mixed-methods projects. These studies help clients understand patterns, experiences, and outcomes in real-world contexts. Grounded in equity and decolonizing principles, our work bridges scientific precision with community relevance producing findings that inform discovery, policy, and practice.

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  • Strong partnerships are the foundation of impactful research. Our team supports authentic engagement with participants, clients, and community partners, alongside strategic collaboration with government, health authorities, and cross-disciplinary leaders. Whether through advisory boards, co-design processes, or system-level partnerships, we make sure relationships are meaningful, accountable, and built to last.

  • We build pragmatic, scientifically sound studies ranging from behavioural RCTs and cohort studies to cross-sectional and longitudinal designs. Our team develops study frameworks, sampling strategies, and operational plans that ensure research questions are clear, feasible, and answerable. Whether you’re exploring proof-of-concept ideas or assessing population-level outcomes, we help you choose the right design and tools to generate meaningful evidence.

  • We navigate complex ethics and governance processes with care and precision. Our team prepares REB submissions, consent materials, and data management plans that protect participant rights and privacy while respecting Indigenous data sovereignty and OCAP® principles. We also advise on data stewardship, ownership, and sharing strategies that align with community priorities.

  • We design and deliver rigorous qualitative and mixed-methods studies that centre participant voice and lived/living experience. Our services include study design, tool development, interviewing, focus groups, coding, and analysis. Whether embedded within a broader RCT or implemented as a stand-alone community study, we ensure findings are robust, contextually grounded, and actionable.

  • We conduct structured reviews to synthesize evidence across fields and identify trends, gaps, and best practices. From search strategy and screening to appraisal and synthesis, our reviews build a strong foundation for new studies, grant submissions, or policy change.

  • Good evidence starts with good data. We design and implement quantitative and qualitative data collection systems from survey instruments and mobile data capture tools to standardized fieldwork/outreach protocols. Our team provides descriptive, inferential, and thematic analysis, ensuring results are rigorous, relevant, and ready to inform action.

  • We help build the skills and confidence of research teams, partners, and community collaborators. Training covers a range of topics including participatory methods, trauma-informed engagement, data collection, analysis, and ethical practice with the overarching goal to create shared ownership long-term capacity.

  • We transform research findings into products that drive change: strategic reports, briefs, infographics, clinical tools, publications, and community-facing materials. Each output is tailored to its audience, ensuring evidence reaches the people and systems positioned to act on it.

Case Studies

  • Multi-Centre Trial for the Treatment of Methamphetamine use Disorder

    CRISM

    Make It

  • Clinical Trial for Therapeutic Mobile Applications for Youth with Psychosis

    Centre hospitalier de I’Université de Montréal (CHUM)

    Make It

  • Phase II Trial with Psilocybin for End-of-Life Oncology Patients

    Roots to Thrive

    Click Here

  • Advancing Cannabis Intervention Research to Address PTSD in Veterans

    MAPS

    Click Here

You have a vision. We make it research-ready.

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  • Roots to Thrive

    “I can’t say enough about what a pleasure it has been to work with the Changemark team.  They jumped in on short notice. With this being our maiden voyage in clinical trials, their ‘can do’ way of being immediately neutralized our stress levels. They met us where we were at (making the process practical and understandable) and had a mentorship mindset from day one. There was no question or challenge left unaddressed.  Every step was done with high integrity and relationships were always put first. It felt like they had our best interests in mind from day one. As a non-profit, and university representative, I am cautious of how I steward the funds in my care – and on numerous occasions, suggestions were made that would provide efficiencies (even if it meant less funds going their way).  Finally, perhaps most importantly, it felt like working among friends.”

    - Dr. Shannon Dames // Research and Development Director

  • Centre hospitalier de I’Université de Montréal (CHUM)

    “I have worked with Changemark for 5 years and have contracted their services for clinical trial protocol development for cannabis, and project management on a series of multi-centre trials involving mobile health interventions for youth with psychosis who use cannabis. The quality of their work is high and so is their ability work with team members. I will continue to work with them on studies and value very much the experience they bring to the team and their collaborative work style.“

    - Dr. Didier Jutras-Aswad // Head of Psychiatry at Cr-CHUM, Montreal, Quebec

  • Centre for Advancing Health Outcomes

    “We engaged Changemark seeking qualitative analysis services for an Injectable opioid agonist treatment study. The analyst we worked with was outstanding, professional, great fit for the team, knowledgeable, cooperative, and produced exceptional work products. We have since re-engaged Changemark for additional work and look forward to continued partnership on future research.“

    - Dr. Eugenia Oviedo Joekes // Research Scientist

  • Centre hospitalier de I’Université de Montréal (CHUM)

    “We hired Changemark to manage a nationwide research program that developed interventions to treat youth with co-occurring psychosis and cannabis use. Working with Changemark on this project was a true pleasure and they added tremendous value to our research. After the experience we had on this project, we hired them again for some of our biggest and most ambitious projects. They are now responsible for the development, project management and implementation of our two national trials evaluating mobile health interventions for youth with psychosis and co-occurring cannabis use.   

    Due to Changemarks extensive experience with clinical trials, specifically in the area of substance use combined with their outstanding performance and professionalism on previous jobs, we have once again hired them for regulatory and project management services for a multi-centre clinical trials evaluating the efficacy of a pharmaceutical and engagement based contingency management in the treatment of methamphetamine use disorder.”

    -  Pamela LeChance Touchette // Director of the Center for Expertise and Collaboration in Concomitant Disorders (CECTC) // Research Associate

  • Centre for Gender & Sexuality Health Equity

    “We highly recommend A.J. Lowik as a consultant for trans-inclusive research. As the Gender Equity Advisory for the Centre for Gender and Sexual Health Equity, A.J. supported our two longitudinal cohort studies to implement important changes to enhance gender-inclusivity in our quantitative questionnaires. A.J. has been responsive, thorough and professional in their approach and creates a supportive and welcoming environment to discuss complex and important issues related to measurement of gender identity and trans health. A.J. demonstrates enthusiasm and passion for trans-inclusive research as well as an extensive breadth of knowledge and expertise, working efficiently and independently to help achieve research goals. We continue to learn so much and very much enjoy working with A.J. as a Gender Equity Advisor. Thank you A.J.!“

    - Dr. Shira Goldenberg // SFU, CGSHE and Dr. Kathleen Deering // UBC, CGSHE

  • Centre hospitalier de I’Université de Montréal (CHUM)

    “Aïssata was instrumental in all phases of an implementation science project working to implement provision of take-home naloxone and initiation of opioid agonist treatment in emergency departments for people with opioid use disorder. As a senior research management professional, she effectively managed all phases of the project, from hiring, training, and supervising staff to managing contracts and stewarding the reporting process.  

    Aissata was indispensable in finding solutions to barriers at all stages, from project design, pre-implementation, implementation, and data collection through analysis and publication of results. Our work was immeasurably aided by the comprehensive financial forecast she provided. Throughout the project, she was straightforward, efficient, and knowledgeable. Aïssata championed the project from start to finish, and was a delight to work with.”

    - Dr. Annie Talbot // Co-directrice médicale, Direction Coordination Réseau CHUM, Clinicienne–Chercheur // Centre hospitalier de Université de Montréal et professeure