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