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

Clinical Study Reports: Reports written to ICH-E3 standards.

Safety Narratives: Writing safety narratives for clinical study reports.

Common Technical Document (CTD): Clinical Overviews (2.5) and Summaries (2.7).

Literature Reviews:  To support research planning and CE marking of medical devices.

Market assessments:
Using information gathered from desk research and interviews with key opinion leaders combined with clinical and regulatory insight to produce incisive reports tailored to the client’s needs. Market assessments are conducted with Consolida Limited, an experienced Research and Commercialisation Consultancy.

Other Services

offered by Sylexis include preparation of:

• Investigator’s Brochures, Patient Information & Consent Forms and Study Protocols all to ICH-E6 standards;
• Periodic Safety Update Reports (PSURs) to ICH-E2C standards.

All projects benefit from our considerable practical experience of designing and conducting clinical trials in several therapeutic areas.  Work is conducted using either in-house or client templates and SOPs.