OUR SERVICES
We provide a variety of traditional outsourced services to meet your needs. These are designed to build a solid foundation for your study, ensuring you have a smooth path to success.
Quality Control Visits
Our Quality Control Monitors provide essential CRO oversight, assessing the proficiency of the CRO monitor to conduct assigned tasks and adherence to the Clinical Monitoring Plan. They also report on the compliance of the site according to ICH-GCP, inclusion exclusion criteria, safety monitoring and risk assessment.
Project Management
Our experienced project managers can initiate, plan, execute, control and close a study in line with your goals and specific success criteria. We have a global focus, allowing us to deliver project managers for both US-based and international clinical trials.
Senior Level CRAs
Experts in their local territory and regulations, our senior-level CRAs can give you unrivalled insights into key regions. Each has an average of 15 years’ experience; many are multi-lingual and can monitor across different countries.
Medical Monitor
Our experienced pharmaceutical physicians uphold the highest standards of medical support, interim management and emergency intervention. They are experienced in medical affairs and clinical development, with a wide array of disease indications.
Regulatory Services
We can perform your National Competent Authority and Ethics submissions and support all regulatory services throughout the lifecycle of your study. Our experts can guide you on New Clinical Trials Regulations and the EU Voluntary Harmonisation Procedure.
Inspection Readiness
We take the stress out of auditing, with resources to conduct GCP Investigator Site audits (Phase I–IV), Vendor Qualification and In-process audits, Internal Process, GMP and GLP audits, and Gap Analysis. We can also support GCP and Site Management training, Mock Inspections, Inspection Preparation, Assists at Inspections and advice on inspection responses.
Rescue Teams
If an issue occurs, we can jump in and support you with a co-monitoring service. We can help you quickly identify experienced consultants who can steer you through a busy or rough period for a short term or even longer duration, if needed.
Medical Writing
Our medical writers focus on Study Protocols, Patient Information Leaflets, Clinical Study Reports, Manuscripts, Product Monographs, Paediatric Investigational Plans, Risk Management Plans, Press Releases and Clinical Summaries, to name a few.
Supplementary Main Services
We fill all types of unique roles for our clients, from report reviews and quality management to site feasibility and study activation roles.