CLINICAL RESEARCH
Services
A fully integrated third-party collaborator.
Salix employs a decentralized clinical trial model, substantially cutting down on research costs. This eliminates obstacles for small to medium-sized companies and opens possibilities for industries like supplements and Natural Health Products, Cannabis Products, Cosmetics and Health Foods to bring health claims to fruition.
SPONSOR ACTIVITIES
Looking for seamless clinical research management? Our services cover protocol design, document management, regulatory compliance, vendor qualification, site selection, and training. Trust us to navigate your journey with precision, ensuring efficiency and adherence to the highest standards every step of the way.
Quality Assurance
Want to ensure top-quality clinical trials? Our services cover SOP creation, record-keeping, data integrity, auditing, risk assessment, and compliance monitoring, ensuring regulatory compliance and industry best practices. Trust us to maintain your data’s integrity and uphold quality throughout your research journey.
SITE ACTIVITIES
Our site activities encompass specialty services tailored to diverse categories and products, with flexibility to meet your unique needs effectively. We excel in patient recruitment strategies, site management, monitoring, and adverse event reporting, ensuring a comprehensive approach to support your clinical research objectives.
Sponsor activities
protocol design & ongoing management
Revolutionizing clinical research, Salix adopts a modernized approach through decentralized clinical trials, substantially reducing research costs. This begins with protocol design, prioritizing efficiency and eliminating redundancy, while upholding the highest ethical standards in accordance with Good Clinical Practices, ICH E6(R2) guidelines, and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), Federal regulations governing Informed Consent (21 CFR 50) and Drug Regulations (21 CFR 312), as well as the World Medical Association Declaration of Helsinki.
investigational brochure & ongoing management
Crafting an Investigators’ Brochure necessitates a delicate balance of scientific precision and communicative clarity. We are dedicated to producing meticulously researched and expertly written brochures tailored to meet the unique needs of clinical research endeavors. We diligently synthesize complex data, elucidate study objectives, and outline investigational plans with clarity and depth. Our team, well-versed in regulatory requirements and industry standards, ensures that every aspect of the brochure adheres to rigorous scientific integrity while remaining accessible to diverse stakeholders. Our Investigators’ Brochures stand as an indispensable resource about the investigational product or drug to the investigators involved in the trial. It supports informed decision-making, ensures regulatory compliance, and fosters collaboration among research teams, regulatory authorities, and sponsors throughout the clinical trial journey.
Trust us to transform your clinical trial data into a compelling narrative that advances medical knowledge and promotes patient safety.
Submission and management of clinical trial applications
Welcome to our comprehensive services for the submission of clinical trials in the USA and Canada. We specialize in guiding you through the intricate process of regulatory compliance, ensuring smooth and efficient submissions for your clinical trials. Our services encompass every stage of the submission process, from initial planning to final documentation.
One of our key offerings is the development of the Quality Overall Summary (QOS) report, a critical component of your regulatory submission. Our team of experts meticulously compiles and crafts the QOS report, providing a comprehensive overview of the quality aspects of your clinical trial data. With a keen eye for detail and a deep understanding of regulatory requirements, we ensure that your QOS report meets the highest standards of accuracy and completeness, facilitating the approval process.
Our experienced professionals streamline the data consolidation and presentation process, organizing your trial data into a coherent and structured format that meets regulatory expectations. From clinical study reports to nonclinical and chemistry, manufacturing, and controls (CMC) data, we ensure that every aspect is meticulously documented and presented to facilitate regulatory review.
QUALITY ASSURANCE
Quality assurance
When it comes to maintaining the utmost standards of quality assurance in your clinical trials, look no further. Our comprehensive suite of services encompasses every aspect, ensuring meticulous attention to detail from the crafting of robust Standard Operating Procedures (SOPs) to the meticulous record-keeping required for safeguarding data integrity. We go above and beyond to ensure that every facet of your trial aligns with regulatory requirements and industry best practices. Our expertise extends to a wide array of quality assurance activities, including thorough auditing, meticulous risk assessment, and vigilant compliance monitoring. You can trust us to uphold the integrity of your data and maintain the highest standards of quality throughout every step of your clinical research journey.
SITE ACTIVITIES
SITE SERVICES
Our site activities go beyond traditional methods, utilizing decentralized models and innovative approaches to boost both the cost-effectiveness and efficiency of our services. Customized to suit various categories and products, our services offer unmatched flexibility to address your unique needs effectively. Alongside these we pioneer in patient recruitment strategies, site management, vigilant monitoring, and delivering thorough adverse event reporting. This holistic approach is designed not just to meet, but to exceed your clinical research objectives, ensuring the best possible outcomes throughout your journey.
Why choose us? Many perceive clinical research as unattainable due to regulatory constraints and high costs, however, our innovative approach makes it more accessible, talk to us to substantiate your health claim.
Contact us to find out more about our innovative approach to clinical trials.