PREMIUM CLINICAL TRIALS

Substantiating Success in the Natural Health Product Industry

CLINICAL TRIAL DESIGN AND EXECUTION

Backed by a vast network of scientific research, legal, and medical professionals, KGK’s team of experts manages every step of designing and executing the perfect trial to substantiate the efficacy and safety of your product.

From protocol development and regulatory approvals to recruiting and seeing participants, managing data, and compiling results into a comprehensive final report, we put our expertise to work for you. We provide a professionally managed project from end to end, ensuring it meets the highest quality standards.

KGK’s strategy places primary focus on the client’s business—focusing on desired outcomes, the product, and the market in which it will be sold. Based on these requirements, KGK’s team develops a customized plan to ensure successful and timely results.

PROTOCOL & IB DEVELOPMENT

Once the strategy is defined, KGK Science will develop a high-quality, well-defined, and operationally sound protocol that serves as the blueprint for your clinical trial. Built upon a foundation of evidence-based literature and over two decades of clinical trial experience, our experienced team meticulously crafts a protocol that outlines the study objectives, design, methodology, statistical considerations, and operational aspects.

Adhering to ICH guidelines and the highest scientific standards, our protocols are designed to provide robust scientific evidence to support your claims while ensuring a smooth approval process with regulatory and ethics authorities.

REGULATORY SUBMISSION AND CONSULTING

As a full-service CRO, KGK Science has a dedicated team of regulatory professionals to manage all aspects of regulatory and ethics submissions for your clinical trials and product approvals. Led by a former FDA federal regulator, our team ensures that your study meets the requirements of relevant authorities, including Health Canada, FDA, EFSA, and other global entities. We work directly with your team to develop and submit the necessary materials, handling all correspondence with regulatory boards until approvals are received, ensuring a seamless end-to-end process.

In addition to handling submissions for trials conducted with us, our team of regulatory experts is available to provide consulting throughout the clinical trial process. KGK can also be contracted to submit to a regulatory board on your behalf for a clinical trial being run at an outside site or to obtain product approvals, offering you comprehensive support no matter where your study is conducted.

PARTICIPANT RECRUITMENT

Recruitment can be a significant obstacle to successfully completing a clinical trial. At KGK, we understand the critical importance of enrolling the right participants, and our specialized marketing and recruitment team is dedicated to overcoming this challenge. We develop and implement customized strategies that target our database of over 45,000 participants and beyond, ensuring we connect with the right demographic to meet the specific needs of your study.

Working closely with our research team, dedicated project managers, and clinic staff, we craft a targeted marketing plan designed to achieve trial outcomes and provide positive experiences for our participants. Our comprehensive recruitment services include:

Strategic marketing plan development
Advertising content creation and regulatory review
Execution of digital and traditional marketing campaigns
A professionally staffed Recruitment Communication Center for telephone screening, clinic appointment booking, and customer service
Ongoing recruitment monitoring and reporting

But it’s not just about reaching the right audience; accurate planning is essential. Using a statistical feasibility model, we develop a custom timeline that assesses the time required for recruitment, providing you with options to achieve the fastest and most cost-effective enrollment. Our approach ensures that your trial remains on track, with timely and efficient participant recruitment.

STUDY CONDUCT

Our experienced clinical team manages every aspect of the study conduct, from participant screening and consent to data collection and monitoring. We ensure that the study is executed according to the protocol, with strict adherence to Good Clinical Practice (GCP) standards. This minimizes risk and maximizes data integrity, ensuring reliable and reproducible results.

Clinical Research Sites

KGK’s state of the art clinical trial center is equipped to handle the most innovative of studies while offering our participants a comfortable and safe environment, thereby ensuring high-quality results. Additionally, we emphasize participant education to ensure they understand the clinical trial process fully, thereby instilling confidence and minimizing participant attrition rates for our sponsors.

Multiple Private Exam Rooms.
Dedicated GCP-trained clinical research staff.
12 Lead ECG, 32-channel EEG, remote EEG and actigraphy, Dynavision D2 device for neurocognitive assessments, DEXA scanner, among other specialized research equipment.
Secured file and medication storage facilities with 24-hour accessibility & security exceeding standards.
On-site Clinical Research Associates to perform monitoring and quality assurance utilizing validated Electronic Data Capture (EDC) systems to allow point of visit data entry during participant visits.
Central location in London Ontario, home to Western University (40,000+ students), Fanshawe College (40,000+ students) and the largest hospital in Southwestern Ontario.
Over 45,000 participants in database that are potential subjects for studies.

QUALITY ASSURANCE

Quality is at the core of everything we do. Our Quality Assurance (QA) team conducts rigorous oversight throughout the trial, ensuring compliance with GCP, regulatory requirements, and the highest ethical standards. We perform regular audits, monitor data integrity, and address any issues promptly to ensure that your trial meets the most stringent quality benchmarks.

STATISTICAL ANALYSIS AND COMPREHENSIVE FINAL REPORT

KGK’s in-house biostatisticians provide comprehensive statistical analysis to interpret the data generated during the trial. The Statistical Analysis Plan is developed prior to the completion of study recruitment, ensuring a clear framework for data evaluation. We apply sophisticated statistical methodologies to ensure robust, accurate, and meaningful results. Whether it’s primary efficacy outcomes or exploratory endpoints, our team delivers clear, actionable insights that drive decision-making.

Upon completion of a clinical trial, all KGK Science clients receive a Comprehensive Final Report written in accordance with ICH guidelines with complete interpretation of the analyzed data. Your final report will provide you with a high-level review of the study as well as results and conclusions, compiled in a format that can be submitted to any regulatory agency, as is.

Each Comprehensive Final Report includes:

Introduction & rationale for the study.
Executive Summary
Complete methodologies
Statistical methods
All results (efficacy, safety, subgroup analysis, responders, etc.)
Interpretation
Discussion

MANUSCRIPT WRITING AND PUBLICATION

At KGK Science, we understand the critical role that publishing plays in showcasing research outcomes and driving industry innovation. Our Manuscript Writing and Journal Publication Services are designed to support our clients in effectively sharing their clinical and scientific findings with the global community.

Comprehensive Manuscript Development:

Expert Writing Team: Our skilled scientific writers craft manuscripts that adhere to the highest academic and industry standards.
Tailored Content: We ensure the content aligns with your research goals and targets the appropriate audience.
Data Integration: Our team excels in integrating complex clinical trial data into clear, compelling narratives.

Journal Selection and Submission:

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