Generally our research unit only take part in later phase studies where the drug or treatment has already been extensively tested in both laboratories and humans for side effects.
Before consenting to any clinical trial, potential participants are given very detailed information about what the study will involve and the possible risks and side effects. This information is approved by an independent ethics committee who ensure that the patient’s safety and care is considered above all study activities.
During a study participants see one of our Doctors at every visit and are monitored carefully for any ill-effects or reactions to the study treatment.
Sponsors respect the privacy of study participants and safeguard the confidentiality of their medical information in accordance with all applicable laws and regulations. While access to confidential medical records may at times be necessary to verify clinical information, no information that identifies individual participants is retained by Sponsors.
In most cases, there is no cost to you to participate in a clinical trial. Your medication, treatment and medical appointments relating to the study will be free of charge. However, you will be required to attend the clinic at regular intervals and in certain instances there may be compensation available for time and travel expenses.
Information for sponsors
We welcome enquiries from potential sponsors at any time. Please contact us for further information.
Our Clinical Research team consists of a dedicated team of study coordinators, research nurses and a clinical trial assistant. Drawing on many years of experience in clinical trials, our investigators include both general practitioners and clinical specialists, all of whom undergo regular training in GCP and specific study procedures.
Our Clinical Research Unit is conveniently placed within Holdsworth House Medical Practice. Our dedicated, secure space includes a temperature-controlled laboratory for processing and shipping of specimens and storage of investigational product. We have alarmed and monitored refrigerators and freezers, an incubator and a refrigerated centrifuge.
Our research staff are IATA certified and proficient in venepuncture, spirometry, ECGs and other clinical assessments. All staff are regularly trained in GCP and are competent in using various eCRFs, including INFORM, Oracle, iMedidata and Viedoc.
Facilities are available for CRAs to conduct their monitoring visits with access to computers and relevant study documents.
As an independent body, Holdsworth House Clinical Research can use a central ethics committee which allows for rapid submission and turn-around of applications and expedited study start-up. Our experienced study team are often called upon to be lead site for multi-site applications and can guarantee a fast and efficient submission process.
Our rapid response times also ensure that contract and budget negotiations are dealt with quickly and efficiently.