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Clinical study management

Study management is critical to the success of every project. Our experienced professionals deliver superior service by taking a collaborative approach to study management. This approach, combined with exceptional organizational and interpersonal skills, creates a responsive, client-driven environment.

We manage each step of the process, from site selection and feasibility assessments to start-up, study planning, risk management and interaction with regulatory authorities and ethics committees.

Clinical monitoring

Our clinical research associates (CRAs) are known for their outstanding client service, attention to detail and in-depth knowledge of industry regulations and guidelines. They verify compliance with protocols, quality standards, data collection and regulatory guidelines—ensuring the highest quality data for your clinical trial. 

We provide site selection, site initiation, interim monitoring and close-out visits, as well as remote monitoring, site personnel training, mentoring and guidance. We also assess protocol compliance and data integrity, as well as a host of other monitoring services.

Data management

We offer a full spectrum of data management services and expertise to optimize your data. Our clinical data managers rigorously follow standard operating procedures that encompass security, industry regulations and ICH/GCP. They work collaboratively and cross-functionally to ensure all stakeholders’ needs are met. We use a comprehensive, but easy-to-use, cloud-based clinical data management platform that supports a wide range of study types and designs. 

From data management planning and CRF and database design to EDC database build and role-based security and access control, we have you covered.


Biostatistical design and analysis are central elements of any clinical trial. Establishing a sound biostatistical plan results in optimal study design and high-quality data output. Comprehensive statistical input during the early stages of a clinical development program decreases overall costs and accelerates timelines to regulatory approval. 

We manage sample size calculation, protocol development support, statistical analysis plans, interim and final data analysis, support for medical writers and more.

Quality assurance

Our quality assurance team provides compliance oversight and guidance through carefully planned audits and detailed reports. This allows continuous process improvement to ensure the ongoing effectiveness of your clinical trial.

We also offer quality assurance services that are independent audits of clinical investigational sites, processes, documentation and assessment of the quality of the data collected and processed.

End-to-end support for your clinical research

Calian has the knowledge and experience to support you at every stage of your clinical research and help you get your product approved.

Experienced medical writers

Our experienced medical writers deliver exceptional quality across a wide range of subject matter. We provide our clients with the highest scientific standards that meet all international guidelines and regulations. 

  • Comprehensive literature reviews
  • Systematic reviews
  • Clinical regulatory module preparation
  • Phase I-IV study protocols
  • Investigational drug brochures
  • Clinical study reports and safety narratives
  • Peer-reviewed original manuscripts and review papers
  • Presentation posters and abstracts
  • Technical briefs
  • Training manuals

Regulatory support

Calian’s CRO services division provides regulatory support for a wide range of therapeutic products and indications for national and international applications.

Regulatory affairs consultants provide regulatory and product feasibility advice on the development and commercial production of therapeutic, biologic and device products.   


We understand the importance of ensuring drug safety and minimizing risks associated with the use of medication. Our pharmacovigilance services are designed to help our clients comply with regulatory requirements, identify and assess potential safety concerns, and monitor adverse events related to their products.

  • Project-specific training
  • Input on protocols, investigator brochures, informed consent forms, case report forms, data management and validation plans
  • Development of the safety management plan
  • Serious adverse event (SAE) Management
  • Medical coding review
  • Safety reviews
  • 24/7 medical oversight

Safety and integrity

A data and safety monitoring board (DSMB) is an independent group of experts that objectively reviews trials on an ongoing basis to ensure the safety of study subjects and the validity and integrity of the data.

  • Developing DSMB charter
  • Identifying and contracting with DSMB members
  • Monitoring conflict of interest and financial disclosure for DSMB members
  • Preparing DSMB meetings (e.g. scheduling, generation and validation of applicable tables, listings and figures)
  • DSMB meeting execution and follow-up (including communication with sponsor, ethics and regulatory bodies, as per the DSMB Charter).

Better patient engagement

Our decentralized clinical trial services are patient-centric and designed to improve the patient’s experience, which leads to better patient engagement and increased retention rates. We make it easy for patients to participate, by bringing trial activities to them wherever they are located: home, work or in-clinic. This allows us to reach a larger, more diverse pool of patients for your clinical trial. 

Real-world evidence

Data about real-world patient experience has the potential to improve the quality and delivery of medical care, reduce overall costs, improve patient outcomes, inform marketing strategies, and potentially reveal new indications. These data help fill the knowledge gap between clinical trials and actual clinical practice. Calian offers custom-designed and insightful qualitative and quantitative real-world data (RWD) collection as part of our patient programs, enabling real-world evidence (RWE) generation.

Patient recruitment for clinical trials

Reach thousands of  patients every month through PrimacyTV, with a range of available services—from playing digital advertisements in Primacy clinics, to creating and implementing customized television ads to inform patients of available clinical studies. Learn more about our individualized services to see which one is right for you.

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Physician recruitment for clinical trials

Calian ensures your clinical trial is appropriately staffed by taking care of physician recruitment and retention. We draw on our vast network of qualified and experienced physicians to select and engage physicians with related clinical interests and expertise to support your trial and ensure its success. 

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Social responsibility at Calian

Committed to social responsibility.

ESG—more than a buzzword.

Our vision builds on our mission, values, historical commitment to social responsibility and key competencies. It provides a framework and focus for our activities and corporate communications related to ESG (Environmental Social Governance).

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Your service inspires us.

Proudly welcoming  100+ veterans to our team every year

Their expertise enriches our solutions, and hiring military spouses is our heartfelt way of giving back to the defence community. We’re committed to being there for you, in and out of uniform.

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4,000+ family members connected with family doctors

Our partnership with the Canadian Forces Morale and Welfare Services ensures that military family members are connected with family doctors, hassle-free.

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Building a resilient community together.

$650,000+ in corporate giving

We are woven into our community’s fabric, our support extending to renowned organizations and causes. We’re not just about business; we are about building a supportive and resilient community together.

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Engaging in research that matters.

Our contributions to significant research projects and our focus on environmental safety are unwavering. We’re front-runners in compliance with environmental laws and continually innovate to lessen our ecological footprint.

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Committed to exceeding expectations.

30+ Indigenous community engagements

With a published Indigenous engagement policy, Calian sets out the framework and guidelines for all Calian business activities while being wholly committed to meeting—even exceeding—the five per cent Indigenous participation requirement on all Federal contracts.

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