Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries. Ergomed successfully manages clinical development from Phase I through to late phase programmes, providing clinical development, trial management and pharmacovigilance services to over 100 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology
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Founded in 1997, Ergomed plc is a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs. It operates globally in over 40 countries.
Ergomed plc has two complementary businesses: (1) The Services Business – a well-established, clinical research business providing services to the pharmaceutical and biotechnology industry; and (2) The Co-Development Business – a growing portfolio of partnerships with pharmaceutical and biotech companies, providing its drug development services in exchange for a carried interest in any revenues attributable to the drug asset, including outlicensing milestones as well as sales of the product
Since its formation, Ergomed plc has been providing expertise in clinical development / trial management from the largest pharmaceutical companies, as well as many small and mid-sized drug development companies. Ergomed plc successfully manages clinical development from Phase I through to late phase programmes.
Ergomed plc has a wide therapeutic focus, but has particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed plc believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed plc and the investigational sites involved in clinical trials. As well as providing high quality clinical development services, Ergomed plc is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed plc leverages its expertise and services in return for carried interest in the drugs under development.
The company has planned, managed, monitored, and reported clinical trials with a range of technologies that include small molecule drugs, monoclonal antibodies, tri-functional antibodies, soluble receptors and other targeted agents, cancer vaccines and immunotherapy, radioactive agents, and photodynamic therapies.
ERGOMED provides integrated pharmacovigilance and drug safety services.
Ergomed established its clinical safety system in 2004 using the ARISg safety database combined with the extremely strong medical expertise within the company. Clinical safety assignments for many Phase I – IV trials have been managed across multiple indications. A team of highly trained and experienced staff perform data entry, data review and medical review functions.
The team is supported and monitored by the best international industry drug safety and regulatory consultants all of whom have many years’ experience of European authorities and FDA interactions. Ergomed has selected the ARIS-g safety database as the information technology platform of this unit, a fully validated, industry-standard database created for SAE management, reporting and regulatory reporting (including E2B); the web-based system allows maximum flexibility.
Ergomed offers full biostatistics services for clinical trials (Phase I to IV) and non-interventional studies and retrospective data analysis. Biostatistics is performed by our statisticians who have many years of experience in the pharmaceutical industry and have worked on clinical trials in most therapeutic areas. We use SAS as statistical software, the installations are fully validated as required by international regulations including 21 CRF Part 11.
Our services cover the complete range of your trial from statistical input to the protocol design through randomization, Statistical Analysis Plan (SAP) development, independent statistical support for Data Safety Monitoring Boards (DSMB), Blind Data Review Meetings (BDRM), blinded or unblinded interim analyses, final data analysis, creation of tables, listings and figures for the Clinical Study Report (CSR) to statistical input to the CSR.
We also offer the creation of CDISC SDTM datasets ready for submission to the FDA.
In addition, Ergomed’s sister company PrimeVigilance www.primevigilance.com provides specialized post-marketing pharmacovigilance services and expert consultancy advice across the whole drug safety spectrum.
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