9th May 2013
May Member of the Month: Isca Healthcare Research
Isca Healthcare Research, based near Newport in South Wales, is an established independent provider of expert services in medical device development, pre-clinical testing and evaluation of medical devices, and medical device clinical trials.
Our expertise is based on almost 25 years’ experience in the development of medical devices and their clinical validation in the UK, Europe and internationally.
We work with clients from the UK, mainland Europe, Scandinavia, USA and Australia. They include multi- national medical device corporations, medical device SMEs and start-ups, the NHS, leading UK universities and teaching hospitals, university technology transfer offices, university spin-outs, IP development companies and venture capital organisations.
Services
The services we provide are tailored to the specific needs of our Clients and include:
- Medical device development programme planning
- Medical device clinical development and consultancy
- Design and development of pre-clinical testing protocols
- Medical device clinical trial design
- Identification of, and introduction to, clinical investigators
- Preparation of medical device clinical trial documentation to meet all necessary national and international regulatory requirements and standards, including: protocol design, preparation and writing; design and production of Case Report Forms; preparation of Consent / Patient Information Sheets / SAE Forms; preparation of Investigator Brochures
- Preparation of MHRA submission binders and all associated documentation
- MHRA submissions for clinical trials of non-CE marked devices
- Clinical and pre-clinical trial management
- Clinical study report writing
- Clinical literature reviews for regulatory submissions
- Clinical documentation packages for regulatory submissions
- Pre-audit review of clinical trials and regulatory submission documentation
- Review of Technical File clinical data prior to Notified Body submission
- Ethics committee submissions
Why use Isca Healthcare Research ?
We fully understand, and have experienced first-hand, the developmental, clinical and regulatory pathways that have to be followed to take a medical device from concept to routine use on a patient. We also recognize that successfully negotiating these routes can be very challenging for many of the companies that develop medical devices, the majority of whom are SMEs and often do not have in-house expertise to address ever increasing clinical and regulatory development requirements.
Our core services are complemented by long established links with:
- internationally recognised clinical centres and experienced clinical investigators
- institutions providing “proof of concept” validation for device prototypes
and supported by expert affiliates, who provide:
- specialist regulatory advice
- statistical design for device clinical trials
- statistical review of trial data
We also have a longstanding collaboration with a leading design and development company that has resulted in the successful development and commercialisation of several medical devices.
Recent work
Recent and current projects include the development and clinical testing of medical devices in the following areas: laparoscopic surgery; endoscopic surgery; wound repair scaffolds; urinary catheters; haemodynamic monitoring in intensive care and the operating theatre; diabetic neuropathy; neonatal respiratory monitoring; neonatal intensive care; point of care diagnostics; aortic compliance monitoring.
Contact:
Tel: + 44 (0)1633 423641