Sylexis Limited offers the following services to the pharmaceutical, biotechnology and medical devices industry and to universities and research institutes:

Market assessments:
A detailed understanding of the market for a medical product is crucial in guiding development and planning effective commercialisation. Sylexis draws on its knowledge of clinical practice and of the markets for a range of medical products to execute a programme of information gathering that is tailored to the needs of clients and their products. Intelligence is gained from desk research and interviews with key opinion leaders from academic, clinical and commercial perspectives. If required, interviews can be targeted to generate 'warm leads' for potential licensees of the intellectual property. Sylexis also contributes regulatory insights to assist commercial development planning. The mass of data are distilled into incisive reports that provide detailed descriptions of the market for a product (or range of products). Projects are fixed price and are based on a brief provided by the client and preliminary discussions to ensure that all relevant questions are addressed in the final report. Market assessments are conducted with Gill Howcroft, an experienced Research & Commercialisation Consultant.

Product development planning:
An effective plan is required to bring together the various disciplines, e.g. discovery, non-clinical, clinical, regulatory, commercial, manufacturing etc. to ensure that the right tasks are done, at the right time and to the right standards in order to successfully develop a product. Sylexis works with the project team to produce a development plan for a product.

Literature reviews:
These can be conducted to support research planning, manuscript writing and CE marking of medical devices.

Investigator brochure preparation:
Written to ICH E6 standards

Clinical trial design and protocol writing:
Written to ICH E6 standards and benefiting from Sylexis’s considerable practical experience of conducting clinical trials in several therapeutic areas.

Ethics & regulatory submission document preparation for clinical trials:
Completing submission forms and writing patient information and consent forms.

Safety reports for Ethics & Regulatory review:
Writing annual and quarterly reports.

Medical review of clinical data:
Writing safety narratives, CTD clinical overviews & summaries, periodic safety update reports (PSURs)

Clinical study report writing:
Written to ICH E3 standards

Manuscript writing:
Transforming study reports into manuscripts for publication in medical journals.