Pre-clinical studies establish that products are safe and effective – and pave the way for in-human studies. 

Products must be tested before ensuring that a human clinical trial is necessary. These pre-clinical tests assess the safety and efficacy of a product and are performed using cell or tissue samples, or animal subjects. Our team of toxicology experts ensure your product is safe and ready for in-human trials and our pre-clinical trials ensure that you get the best out of your human trials as well.

Our team, your trial: We manage your clinical trials from start to finish.

A clinical trial stands or falls by how it is managed. prophema’s full-service bespoke clinical trial management oversees all phases of a clinical trial while adhering to your timelines and budget. Through collaboration and communication, we help you make a positive impact on the global health industry. We take ownership of your trials and help you substantiate unique quality, safety and efficacy claims about your product and build industry confidence and consumer trust. 

The perfect protocol guarantees the safety and effectivity of a clinical trial.

Health Canada defines a protocol as a document that outlines the objectives, design, methodology, statistical considerations and organization of a clinical trial, and a protocol document is mandatory for approval by the Regional Ethics Board. Preparing this document is a laborious task, and our team of regulatory experts, armed with deep knowledge about the ins and outs of research protocols, will help you design an impeccable research protocol. 

Be prepared for protocol submission with our assessment and review.

Our protocol review assesses your study protocol or clinical trial application for its fitness prior to submission. Clinical trial applications (CTAs) and CTA amendments will be placed under review after submission. For pharmaceuticals this period is 30 days, for natural health products, it is 90 days. Such protocols must adhere to the Good Clinical Practices outlined in the guidance document  E6(R2), issued by the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH). 

If your protocol does not meet this standard, Health Canada can issue a Not Satisfactory notice in response to your submission. prophema’s team of experts, hailing from multiple relevant fields, will ensure you receive a No Objection Letter by exhaustively reviewing your protocol prior to submission. 

Ensure that your clinical trial stays within its scope, timeline and budget.

Project management is critical to the success of a clinical trial. Managing clinical trials involves risk mitigation, adherence to study timelines and preventing protocol deviations. prophema  manages both your clinical trial and your regulatory submissions, effectively handling the project from start to finish. Our project managers are CAPM and SSM-certified and will manage clinical trials across Phases I-IV and across multiple sites and indications. Every clinical trial managed by prophema is on budget, on time and within its scope. 

Design an air-tight clinical trial, stake your unique claims.

Investing in clinical trial design prevents organizations from making critical and costly errors further down the research process. While many CRO’s offer clinical trial design services, few explain what that entails. At prophema, clinical trial design is tailored to your needs, and is customizable and collaborative. We devise strategies based on your desired research outcomes, the end-product of your research and the target market of your health product. Our experts have years of international experience and expertise in clinical research, regulatory compliance and product development in industries such as natural health products, food and dietary supplements. Our clinical trial design thus ensures you can make and market your products based on unique claims backed by top-grade research. 

Adhere to Good Clinical Practices in the strict regulatory environment of Canada.

The regulatory environment for clinical trials is constantly evolving, as the ambit of Health Canada extends to dietary supplements, natural health products, foods, medical devices and cosmetics and drugs. This is why you need a CRO whose experts have worked with regulatory bodies for years and have a nuanced understanding of regulatory challenges. prophema’s experts have successfully dealt with a wide range of regulatory matters such as safety, quality and compliance, across product categories in the life sciences and food industries. We will assist you in all phases of your clinical research, to ensure you navigate the regulatory landscape with ease. 

Tailor every regulatory submission based on the type of trial and the regulatory body.

Clinical trials cannot proceed without regulatory submissions, and are approved only if submissions adhere to the highest standards, which differ depending on the type of clinical trial and the regulatory body to which the clinical protocol will be submitted. Our team of experts has multi-disciplinary experience, ranging from regulatory affairs and project management to medical writing, data analysis and biostatics: we will ensure that your regulatory submissions will be tailored to your needs even as they live up to the most exacting regulatory standards. 

Support the safety, efficacy and health claims for your NHP’s and ingredients.

NHP trials provide evidence that supports the health claims made for a certain ingredient or product. They also make the case for altered dosages and new health claims. prophema has assisted several NHP firms in their Clinical Trial Application submissions to Health Canada. 

Make health claims backed by impeccable scientific evidence.

Health claims about dietary supplements need to be backed by strong scientific evidence – in the US, both the Food and Drug Administration and the Federal Trade Commission need any proclaimed benefits to be supported by research. 

prophema can assist in designing clinical trials intended to support health claims about dietary supplements – well-designed and controlled clinical trials are considered the highest standard for gathering evidence to substantiate health claims. 

Market the genuine, research-backed health benefits of your foods.

Health Canada regulates functional foods and monitors food health claims to protect consumers from unsubstantiated claims about the benefits of food products. 

Companies selling foods with health claims must provide supporting data from unbiased human clinical studies. Such studies need to assess the safety of functional foods and how they result in improved health, and whether their benefits are generalizable to a large population. 

The critical role of clinical trials in non-therapeutic care products.

Claims regarding cosmetics and personal care products fall into the non-therapeutic category, and as such, do not require prior approval from Health Canada. However, even such claims, whether advertised or included in product labels, are best substantiated by research and help your product stand out from the competition. Increasing consumer awareness has put the onus on companies to make claims that are backed by proper scientific research.  prophema offers extensive services for cosmetic research initiatives. We develop clinical trials designed to support specific advertising claims, and ensure your evidence is as specific as the claims you make. We develop a thorough trial protocol that provides the data you need to substantiate the claims that will make your product unique among competitors. 

Market your medical devices with fool-proof data.

The Medical Devices Bureau of Health Canada has a separate Device Evaluation Division that handles medical device research. Each device must have an Investigational Testing Authorization issued by Health Canada for it to be classed as a medical device. 

According to Health Canada, any instrument, appliance, or component that is made and sold in the diagnosis and treatment of diseases qualifies as a medical device. 

Such devices can hence offer a wide range of functionality, and Health Canada divides such devices into four classes based on risk, with Class I representing the lowest risk and Class IV representing a high-risk medical appliance. Manufacturers must not only ensure the safety and efficacy of their devices, but provide research-backed proof of its use in medical contexts. prophema offers extensive support for medical device clinical trials, including feasibility studies, pivotal studies, regulatory and compliance services, ITA applications

Select the right environment for your trial.

Clinical trials must be conducted at the right site to prevent costly delays, and prophema will help you define your site requirements and your site selection criteria to assess whether our primary site in Toronto suffices for your needs. Based on your parameters, we will also assess the feasibility of your selected site, and perform an SSV (site selection visit) or an SEV (site evaluation visit) to ensure your site will meet your project requirements. 

Our Canadian site offers these advantages: 

Toronto, home to 3 million people of diverse backgrounds and health status, and the Greater Toronto Area, with a population of 3.5 million, enables us to recruit participants without any delay.

Neutraceutical clinical trials in Canada are approved by an independent ethics board (the IRB/REB), and we will assist in obtaining approvals for your clinical trials. 

Ensure your clinical trial runs smoothly, and according to regulatory standards.

It is vital that your clinical trials are conducted without a hitch and in full compliance with good clinical practices issued by regulatory authorities. We monitor the site constantly, tracking participant enrolment, data, protocol adherence, subject safety and regulatory compliance. Our clinical research associates and clinical monitors carry out regular visits to the site throughout the study period to ensure it runs on course. Site monitoring differs based on the sponsor’s specific needs, and as such, prophema’s monitoring plans are tailored to meet them. At prophema, adhering to protocol design and participant safety is a top priority and we will ensure that your clinical trial is running as intended.

Prevent the single most important factor in delayed clinical trials: enrollment failure.

Problems with participant recruitment is the single largest cause of delays in clinical trials. 80% of such delays are directly tied to enrollment failure.

Our team of recruitment experts uses multiple channels to ensure you are provided with participants without any delay. We develop omni-channel marketing campaigns specific to each clinical trial and reach participants through social media, radio, television, search engines and print media, and follow a streamlined ethics review process so that marketing materials get institutional approvals from the IRB or IEC on time, so that your clinical trial has the right participants well in advance. 

Develop your proof-of-concept at the early phase of clinical trials.

The early phase marks the first time in a product’s development cycle when it is tested with human subjects. 

prophema offers a full range of services for early-phase clinical research (Phase I-IIa) at the most advanced facilities to ensure that our sponsors are well-equipped to develop the proof of concept for their products. Our research facility and our clinic at Yorkville, downtown Toronto, ensures we are able to recruit test subjects for any defined study population. Our clinic is easily accessible to all of Toronto and GTA, with a population of over 6.5 million from diverse backgrounds and health statuses. 

A full range of services for Phase II and Phase III nutraceutical and medical device trials.

Phase II Studies

Phase II trials evaluate the safety of products, like Phase I, though they also assess the effectivity of the product, on a larger group of test participants. Unlike drug trials, nutraceutical trials can begin at Phase II, if you provide evidence that the product is safe for human use.

Phase III Studies

At this stage, the product is tested on a much large population, with participants enrolled at different sites or even different countries. Phase III studies are meant to furnish more evidence for effects shown in Phase II, generate more safety data and even form the basis of product labelling. Any disease prevention claim needs to be substantiated with at least one Phase III trial. Recruitment is often a challenge for Phase III trials and the success of this trial depends on the insights from early phase data, making an appropriate protocol design based on feasibility studies and early phase data key to a successful Phase III trial.

We hence offer a wide range of services to maximize the gains from these larger-scale studies, including bioanalysis, biostatistics, data management, medical writing, protocol design, case reports, site management and site monitoring.

Secure your product post regulatory approval.

The Phase IV clinical trial, or a post-approval study is conducted after the product has gained regulatory approval and is meant to gain additional safety information such as a product’s side effects, its metabolism and the physiological process by which it achieves its effects. These trials study the product in a real-world population.

Phase IV trials are exempted from CTA filing, though they still require REB approval, and adherence to Good Clinical Practices, and their success is tied to accurate record-keeping due to the diverse variables in studying a drug in the real world. Our team can assist in all documentation tasks related to the Phase IV trials, including protocol design, trial management and analysis and reporting.

Achieve the best desired outcome with our feasibility study.

Few clinical trials can succeed without a rock-solid feasibility study ahead of the trials process. Our feasibility assessment includes protocol review, assessing enrollment potential, site eligibility, a review of the possible regulatory challenges and assessing the standard of care during the time a study is conducted. prophema ensures that the single largest cause of clinical trial delay, enrollment failure, is prevented by validating the enrollment potential of a clinical trial, in a way to best fit a sponsor’s budget, timeline and outcomes.

Gain approvals from critical regulatory bodies.

A clinical trial application is submitted to a regulator such as Health Canada, a body that outlines best practices and regulatory guidelines for clinical trials. A CTA must be submitted to gain authorization to conduct a clinical trial within the jurisdiction of a regulator such as Health Canada, and contains all the key information about your product and proposed clinical trials.

CTA’s must be filed before any sponsor can start a new trial. CTA’s are required for a wide range of studies, including trials in Phases I through III of product development and any study involving human participants. Our team boasts experience in regulatory compliance, project management, biostatistics, data analysis and more, and will ensure that your CTA’s meet the most rigorous standards.

State-of-the-art bioanalytics throughout the clinical trial cycle.

prophema covers every phase of your clinical trial – from devising methods to validation, stability testing and sample analysis. Bioanalytics – the quantitative measurements of compounds or metabolites in blood, plasma, serum or tissues – yields vital information throughout every phase of product development. 

Our expert team specializes in PK/TK sample analytics using various methods: ultra-performance liquid chromatography-mass spectrometry (UPLC/MS), and liquid and gas chromatography. We follow guidelines laid down by regulators like Health Canada and the US FDA, and our bioanalytic processes are both GLP and GCP-compliant. 

Our bioanalytics guarantees you accurate data based on rigorous testing and regulatory-compliant best practices, and ensures the success of both pre-clinical and clinical programs. 

Our bioanalytical services cover pharmacokinetic studies, bioavailability and bioequivalence studies and drug interaction studies. 

We ensure your drugs are safe and effective.

Prophema offers pharmacovigilance services that are carefully calibrated to cover every phase of any clinical trial. We constantly assess the risk-to-benefit ratio of your product at every critical phase: Serious Adverse Event Reporting (SAER) is considered mandatory for most federal health agencies and involves tracking patients for adverse effects, and requires an irreproachable monitoring program after your product hits the market. 

Our Adverse Event Reporting / Adverse Reaction Reporting services ensure that you track your drug’s safety implications not only during the research phase, but also when it has hit your target market population.  

See the big picture: Biostatics in measuring the overall efficacy of clinical trials.

Less than 10% of investigational products make past clinical trials to post-marketing surveillance, because they lack a rigorous plan for the statistical analysis of product efficacy. We carry out statistical analytics using the best software and the most experienced technicians in order that you may achieve your clinical goals, and our services are adapted to every clinical trial phase. 

Our services are compliant with ICH-GCP standards and our state-of-the-art tools can easily handle the most complex statistical problems, especially when used by our team, which is experienced in multiple therapeutic fields and product types such as functional foods, natural health products and pharmaceuticals. 

Present your advances in the clearest documentation.

We have years of experience in writing for regulatory bodies, and our team has over 200 papers published in scientific journals and has taken part in over 450 clinical trials. We have written NHP and dietary supplement applications to regulators across the globe. 

Our range of services covers everything from protocol design to informed consent forms, clinical reports, electronic common technical documents, site information forms, and an exhaustive range of clinical trial documentation services. We also prepare abstracts, research posters, white papers, journal articles and slide decks. 

We record every step of your mission in making a positive difference in health care.