Surgical Trials

Wellspring's Dr Catherine Harper has twenty years' experience in surgical trials in the NHS and healthcare industry and her experience ranges from concept through to post marketing studies. She understands the constraints faced by busy Consultant Surgeons and their Surgical teams and has managed trials across a wide range of specialities; namely General, Colorectal & Upper GI, Cardiovascular, Thoracic, Urology, Gynaecology; Orthapaedic, ENT, Maxillofacial; Plastic, Aesthetic and Ophthamology. She has managed a range of surgical trials internationally, including novel biomaterials, implantable devices and medical devices.

It may be that you are researching a new surgical technique versus standard practice, or a novel biometric or implantable device. Either way, Wellspring has the experience to help with all aspects of the trial:

- Getting started

- Help with Clinical Trial Application to MHRA

- Grant Applications

- Ethic Submissions

- Case Report Forms / Monitoring

- Placebos and Comparator Supply

- Sourcing Medical Devices


Wellspring understand that a surgical trial is not the same as a pharmacology trial in any way, for example, a blinded surgical trial requires 2 investigator surgeons not one.

This is because the surgeon operating can only be blinded until the point that the trial procedure takes place - at that point they will become unblinded as such they will know which patient received which treatment. A second investigator surgeon is therefore required who is unaware of which treatment the patients received, who can then follow up the patients blinded. This adds extra constraints on surgical trials as two investigator surgeons are needed per centre.

In addition, at certain times of the year external factors play a part in how successful your trial runs. For example, if there was an Influenza outbreak, hospital beds will be allocated and non elective procedures will halt, thus stalling the trial for several months.

We offer a unique consultancy service and are able to manage any individual aspects, if not all, of your surgical trial. You can be confident that your trial is in experienced hands.

Call us now on +44(0)1302 553020 or Email us here.