A UK clinical research organisation (CRO) offers specialist clinical trials for subcontracting or outsourcing agreements.
A UK clinical research organisation (CRO) offers specialist affordable, scalable clinical trials services for medical device, medical technology and pharmaceutical companies who need to design and run all types of clinical trials in order to gather high quality evidence for their product. The company seeks a subcontracting or outsourcing agreement.
The company is seeking partners within the medical device, medical technology and bio-pharmaceutical industries who are in need of: • Clinical strategy planning • Clinical trial design • Clinical trial management • Clinical Evaluation Report (CER) preparation The company are offering their expertise under outsourcing or subcontracting agreements. In return the partner can expect a high quality tailored service which delivers on the client expectations and budget, and access to the company’s trusted network of associates. All work carried out is in compliance with the Declaration of Helsinki, EU and national legislation wherever applicable.
The UK company was established by experienced global clinical research professionals wanting to offer clients the tailored service they would not otherwise get elsewhere. The company works with all of its clients in partnership, using its vast experience to support them in navigating the complex processes in this sector. It takes into account regulatory, commercial and cost considerations to provide clinical trial design costing which meets client needs and budget. All work undertaken is in compliance with the Declaration of Helsinki, EU and national legislation wherever applicable. The company is able to introduce its clients to a trusted network of established associates offering a host of connected services which are vital to product commercialisation: • Regulatory services and gap analysis • Intellectual property expertise through our preferred legal collaborators • Human factors/patient engagement focus groups • Study design including sample size calculation, literature review, Key opinion leader involvement and selection of appropriate primary end points • Study drug import, packaging, labelling and Qualified Person (QP) services • Study site selection • Ethical and Regulatory submissions • Full trail management to applicable regulatory standards (ISO 14155, ICH GCP) • Study data capture and management through a bespoke study electronic database • Medical writing, including Clinical Evaluation Reports, Clinical Study Reports and all study documentation • UK and Irish Market access • ISO 9001 accredited The company is looking to work with overseas medical device, medical technology and pharmaceutical companies who need to run clinical trials to gather evidence for their product in order to get it to market. They are looking for subcontracting or outsourcing agreements.
Advantages and innovations
This company has many years’ experience in its field and prides itself on its approach to working with clients, always operating with integrity. It works hard to align quickly with clients and their products to fully understand client needs and in-house capabilities. The company performs full literature reviews and works with clinical subject matter experts, to understand the healthcare setting and patient pathway when designing trial protocols. Its bio-statistics partners are experts in intelligent trial design to balance trial costs with the need for the appropriate statistical powering. This results in a robust protocol trial design with the best chance of delivering to time and target in the chosen setting. The company also delivers a full and ongoing risk assessment process which also mitigates the chances of failure or delay in clinical study planning and execution.
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