A UK-based SME is offering a wide range of clinical development services to the pharmaceutical, healthcare, biotechnology, medical device and medical diagnostic industries. The company has particular experience in working with smaller companies and is able to take them through the whole clinical trial process in multiple territories. It is envisaged that this partnership will take the form of a services agreement.
A UK-based SME is offering a wide range of clinical development services to the pharmaceutical, healthcare, biotechnology, medical device and medical diagnostic industries. The SME provides a flexible service and an ability to adapt rapidly to changing study and sponsor requirements. Clinical development is a critical stage in developing new therapeutics, diagnostics and medical devices for the market. It is therefore vital for companies and institutions conducting clinical development to develop the most appropriate study design, select and employ the best sites for the study and have good clinical study management. This can be difficult for smaller companies that can lack the required resources to effectively manage clinical development. The UK-based SME offers a full clinical development service from study conception to the final report and has a strong background of working with smaller clients, including virtual, semi-virtual and start-up companies. They will act as a natural extension of the Sponsor's project team and will guide them through every step of the clinical development process, from study concept design through to delivery of the final clinical study report. That are able to manage clinical studies in all phases, from Phase I first-into-man studies through Phase II, Phase III and beyond into post-market surveillance. The SME is able to provide services to clients to help them with the practicalities of clinical development from designing a study plan, finding trial sites and managing the clinical project through to the data management and statistical analysis of trial data as well as medical writing. They can also help with the legal aspects of clinical studies such as regulatory strategy and regulatory submissions, ethics committee submissions and R&D committee submissions for the UK as well as legal representation for the EU. The SME works across Europe, covering North America with a partner clinical research organisation, and so can coordinate the management and conduct of a study across multiple countries and geographic regions and this includes local regulatory and ethics committee requirements as well as clinical monitoring. The SME is offering its clinical development services to smaller companies that are planning to conduct clinical trials for therapeutics, diagnostics or medical devices. It is envisaged that this partnership will take the form of a services agreement.
Innovations and advantages
Provision of a full clinical development service from study conception to the final report. The SME works with all the major independent Phase I units in the UK and this offers the advantage that the monitoring is truly independent, resulting in higher quality data. They have experience in working with smaller companies and so understands their requirements and concerns, including their financial environment, and can therefore provide a bespoke service responding to their needs. The SME has experience of working across Europe and North America (via a partner clinical research organisation) enabling the SME to coordinate the management and conduct of a study across multiple countries and geographic regions including local regulatory and ethics committee requirements as well as clinical monitoring.
06001002 Clinical Research, Trials
06001005 Diagnostics, Diagnosis
06001012 Medical Research
06001015 Pharmaceutical Products / Drugs
Market application codes
05005022 Other clinical medicine
05007002 Pharmaceuticals/fine chemicals
Area of partner's activity
The SME is looking to provide its range of clinical development services to companies looking to take their therapeutics, diagnostics or medical devices through clinical trials. They are especially looking to work with smaller companies and envisage that the partnership will take the form of a services agreement.