Nutraceutical Clinical Trials

Sponsor a Study

Ingredient suppliers and brand owners work with us to develop high-quality clinical research studies that help to identify how ingredients and products work, to document clinical safety and efficacy, and to provide support for unique claims to expand their product line globally.

Our team of medical and regulatory experts will help guide you through the process of clinical trial design and trial execution. We collaborate with you to build industry and consumer confidence in your brand through clinically demonstrated safety and efficacy. As your clinical trials partner, the mutual goal is to make a positive difference in the global health industry – by substantiating safety, quality, and/or efficacy.

 

dicentra’s CRO Services:

Protocol Design

Protocol Review

Clinical Trial Monitoring

Multi-Centre Trial Management

Regulatory Submissions

Customized CRF / Source Document Design

GCP Compliance Auditing

Our clinical trial process from start to finish:

 

We provide you with a simple process to get your clinical trial started. dicentra will help you design, manage, and execute your clinical trial to the highest level of regulatory and scientific quality.

Develop a Strategy

Our team will work with you to identify the best possible approach to capture your most significant clinical outcomes through tactfully selected clinical analyses.

Establish Budget and Timelines

Clinical trials can be costly and time-consuming but our team will work to ensure you stay within your clinical research budget and remain constantly aware of transparent timelines throughout the whole process.

Design Protocol

A well-designed protocol is critical to achieving your clinical research goals on time and on budget. Let us help you identify the best trial design, trial population and outcomes before designing the best possible protocol for your needs.

Obtain Approvals

We will manage regulatory submissions to gain Health Canada and REB / IRB approval for your trial.

Recruit Subjects

Recruitment is one of the most challenging aspects of a trial, let us take charge of finding quality research subjects to complete your trial safely and on time.

Conduct Study

Our clinical site in downtown Toronto will work to conduct your study with the highest regard for participant safety, data quality and ICH-GCP compliance.

Analyze Results

Strategic analysis of study results by an experienced team of biostatisticians to capture significant clinical endpoints.

Produce Reports

Medical writing that captures your research and significant findings are prepared and for you to submit for publication.

Substantiate Claims

Health claims made on natural health products must be supported by sound clinical research and are crucial to successful product development and marketing.