Flexible and tailored services

Clinical Writing

Includes development of clinical study protocols, patient facing documents (including patient information sheets, informed consent forms) and clinical study reports to ICH E3 or ISO standards.

Regulatory Affairs

Includes the preparation and management of clinical trial applications, substantial amendments and end of trial notifications to the Competent Authorities.

Study/Project Management

A dedicated study/project manager will work with you to develop a comprehensive project plan, providing you with realistic timelines for project delivery. Keeping your project on track and on budget is critical for the success of your study and one of our top priorities. Every stage of your project is carefully managed to ensure it is executed to the highest standards. Innovative, real time reporting throughout the life of your project gives you a clear perspective of where you are at – and where you should be –so that early identification of any issues that arise are identified and immediate action taken.

Monitoring

We utilise hybrid monitoring to ensure we can provide the right level of oversight for your study based on risk. We offer combinations of remote, central and on site monitoring. Our skilled and well-trained monitors ensure the highest quality review of data and effective interaction with study sites and all have experience of working with multiple EDC platforms.

Biostatistics

Our experienced biostatistical partners will work with you proposing statistical approaches, innovative study designs and analytical methodologies and build them into your statistical analysis plan (SAP). Our Biostatistics team can create randomisation schedules, submission ready datasets, TLF generation and reporting, data safety monitoring board (DSMB) outputs and can support interim analysis, exploratory analyses and support for manuscripts and abstracts.

Data Management

We work with highly experienced partners who provide a single platform solution for electronic data capture. The electronic data capture software is fully 21 CFR Part 11 compliant. Full control is provided to assign which users can access, sign and modify forms. It also supports visit scheduling, real-time edit checks,  automated initiation and resolution of queries, real time data listings, and integrates with GlobalTrace EDC to provide kit tracking if required.

Safety Management

We work with you to support the safety management aspects for your trial from assisting with developing the safety sections of your protocol/clinical investigation plan, through to processing of serious adverse events/serious adverse device events (SAEs/SADEs) and expedited reporting of unexpected serious adverse drug/device reactions (SUSARs/USADEs) to the regulatory authorities, ethics committees and investigators. We also have the capabilities to develop robust and applicable safety monitoring plans and manage the set up (and attendance if required), of independent drug safety monitoring committees (IDMCs).

Quality and Compliance

We will ensure a Quality Management Plan (QMP) is produced for your study so you can be assured it is conducted to the highest standards. We can provide CQA services to help our clients and sites develop the most effective methods for correcting and preventing any non-conformities. Among the CQA audits we conduct are: Clinical investigator site audits (routine, directed and pre-inspection audits to help sites prepare for regulatory inspections), clinical study document reviews (Trial Master File and Site File), system audits (in which we assess a client’s standard operating procedures (SOPs) and processes and recommend improvements where needed) and vendor audits (in which auditors evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations). Finally, we can be there to help you through Regulatory Inspections, from preparation and supporting through to the inspection days and assistance in forming responses and Corrective and Preventative Actions plans (CAPAs).