Quality Assurance Ensuring Patient Safety and Data Integrity
Aptus Clinical is committed to delivering quality, regulatory-compliant clinical research services in a professional, efficient, and cost-effective way, while protecting patient safety and data integrity for regulatory submissions.
Our Quality Assurance team is highly experienced in this heavily regulated environment and drive quality management, regulatory compliance and risk management in all projects. We are passionate about delivering compliance alongside making clinical trials as patient centric as possible.
Quality Assurance
Aptus Clinical offer support in the development of regulatory/GDPR documents, process and procedures that are ICH GCP compliant and are required for international drug development. We are committed to building successful partnerships, based on delivering the highest quality services in the most flexible and cost-efficient manner possible.
Our experience enables our team to give honest and open views whilst working with you in a flexible manner to find the best way to progress your clinical trial. We will endeavour to be more than just a CRO and feel like an extension of your team.
Aptus can deliver
QMS
Highly professional, fit for purpose QMS build using a cost-effective modular approach
Experience
An exceptionally competent, experienced, and collaborative in-house team
Advice
Clear advice on compliance strategies to align with global regulatory requirements
Insight
Provision of insightful risk based operational advice
Audit Preparation
Health authority audit preparation
GCP & GMP Audits
Conduct audits to GCP and GMP compliance and regulatory risk
-
Support where you need it
Aptus Clinical's team of experts main focus is transporting medicines to the next step in their development, this is often with First-in-Human) FiH studies where we will support you as much, or as little, as you need to ensure the progression and data that is required. We all want new therapies to reach the market efficiently and Aptus is keen to play its part in puzzle that can anything from regulatory submission to study design.
