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QSS helps companies build the regulatory foundation for clinical development. If you need to understand what preclinical data regulators require before your IND or CTA can be filed, or you are ready to move into clinical trial design, we can help you get it right before the work begins.
Before a clinical trial can begin, regulatory agencies including the FDA and Health Canada require evidence that the investigational product has been adequately characterized and that the proposed human study is supported by sufficient non-clinical data. What that data needs to include, and how it needs to be packaged and presented, depends on your product type, your intended indication, and the jurisdiction you are filing in.
Getting this foundation wrong is costly. Gaps in your non-clinical data package can result in an IND or CTA being placed on clinical hold, delaying your program while studies are repeated or reformatted to meet agency expectations. A clinical trial protocol that does not align with those same expectations creates problems that compound through execution and into submission.
QSS works with companies at the preclinical and design stages to make sure the regulatory requirements are clearly understood, the right studies are planned, and the protocol is built to generate data that will support your submission goals.
We identify what non-clinical data regulators will require for your product and intended indication, advise on study types and data package structure, and help you plan preclinical work that meets FDA, Health Canada, and international agency expectations before you commission studies.
We review your existing preclinical data against regulatory requirements, identify gaps that could result in a clinical hold or agency questions, and advise on how to address them before you file.
We prepare and support submission of Investigational New Drug (IND) applications and Clinical Trial Applications (CTA), including the non-clinical and clinical sections required by FDA and Health Canada to authorize the start of human studies.
We develop or review your clinical trial protocol, including study objectives, design, methodology, eligibility criteria, endpoints, and statistical considerations, ensuring alignment with GCP guidelines and agency expectations.
We advise on the regulatory pathway for your product, support pre-submission meetings with agencies, and help you build a development plan that connects your preclinical and clinical program to your submission goals.
We support the preparation of documentation required for Institutional Review Board or Research Ethics Board review, including the informed consent framework and supporting materials needed for ethics approval.
We assess the practical viability of your proposed trial, including patient population availability, site requirements, and operational logistics, before you commit to a design.
Explore articles, blogs, and videos on preclinical regulatory strategy, study design, and GCP compliance.
Preclinical research refers to the laboratory and animal studies conducted before a product enters human trials. Regulatory agencies require this non-clinical data to establish that an investigational product is sufficiently characterized and that the proposed human study is supported by adequate safety and efficacy evidence. QSS does not conduct laboratory or animal studies, but we advise on what studies regulators require, review existing data packages for gaps, and help you prepare the non-clinical sections of your IND or CTA.
Requirements vary by product type, therapeutic area, and target jurisdiction, but typically include pharmacology data, toxicology studies, pharmacokinetic data, and manufacturing information. The FDA and Health Canada each have specific guidance on what is required and how it should be presented. We review your data against those requirements and identify what needs to be addressed before you file.
An Investigational New Drug (IND) application is the submission required to initiate a clinical trial in the United States under FDA oversight. A Clinical Trial Application (CTA) is the equivalent submission in Canada under Health Canada. Both require a protocol, investigator information, and a non-clinical data package supporting the safety of the investigational product. We prepare both and support follow-up agency interactions.
Good Clinical Practice is the international standard governing how clinical trials are designed, conducted, recorded, and reported. It is required by the FDA, Health Canada, and most major regulatory agencies. Designing your trial in alignment with GCP from the outset protects participant safety, ensures data integrity, and means your results will be accepted by the agencies that review them.
As early as possible. Regulatory input at the preclinical stage helps you plan the right studies the first time, avoid generating data that does not meet agency standards, and structure your development program so the work you do now supports your eventual submission. The cost of fixing a non-clinical data gap after the fact is significantly higher than addressing it during planning.
Talk to a specialist about your SaMD compliance pathway — whether you are determining classification for the first time or preparing a submission for the U.S. market.