Clinical Trial Participation
We are constantly seeking new clinical trial projects to bring to our local community here in Newcastle. We are passionate about providing our community with access to potential new treatments and medical advancements. We are regularly involved in world-first studies for pain management.
Our team of investigative doctors includes a variety of medical specialists and GPs, allowing us to provide a broad spectrum of trial opportunities to our community.
Participants are at the centre of everything we do here at Genesis.
At our established research centre, you will be cared for by a team of dedicated health professionals. You will see trained research coordinators at each study visit who will guide you through every step of your research journey and answer any questions you have. Our medical doctors take great interest in their research projects, ensuring you will be well cared for throughout your journey with us.
What is Involved?
As a clinical trial participant at Genesis Research Services, your clinical trial journey with us may look something like the diagram below. The number of study visits will depend on the trial design and the type of treatment. If the trial involves a surgical procedure or device implant, these will be performed at our partnering day surgery centre or private hospital, which we will organise for you. Throughout every stage of your clinical trial journey, you will be looked after by a dedicated team of health professionals.
If you have any questions about clinical trial participation, view our Frequently Asked Questions or Contact Us.
Study Visits
For more information about what happens at each study visit, click on the headings below, or read our clinical trials blog series.
Pre-Screening
Your first contact with us usually begins with a pre-screening phone call. During this phone call, you will speak with one of our clinical trial coordinators, who will discuss the study with you and ask you a series of questions to determine if you may be eligible to participate in the trial. If you are a suitable trial candidate, you will be booked in for a screening visit at our site. You will also be sent a copy of the participant information sheet, which will tell you all you need to know about the study and what your participation will involve.
Screening Visit
During your first visit to our site, you will meet with the study doctor (investigator) and coordinator. You will discuss the study information and be encouraged to ask any questions before signing the informed consent form. Once consented, the investigator will assess your eligibility to join the trial. This usually involves reviewing your medical history and medications, physical examination, and completing health questionnaires. You may need to get blood tests and/or medical imaging elsewhere, which we will organise for you. If you satisfy all the eligibility criteria, you will be enrolled into the study.
Read more about the screening process here.
Baseline Visit
Sometimes the screening and baseline visits are combined. During this visit, you will complete baseline assessments, which may include health questionnaires, clinical examinations, physical tests, and so on.
If the study is a randomised controlled trial, you will then be randomly assigned to either the study treatment group, or the control group (which may be a placebo). For new drug trials, you will be given the study treatment and may need to stay on site for a specified time to be monitored for possible side effects.
If the study involves a surgery or device implant, the coordinator will organise the procedure booking for you on another day. Some device trials involve a short trial of an external device before receiving an implant. Read more about medical device trials here.
Study Visits
Depending on the trial, you may have multiple, regular follow-up visits to attend. During these visits, you will complete study assessments (often the same ones you did at the baseline visit, plus or minus others). You will need to report any changes in your medication and if you experienced any side effects. You may or may not receive additional doses of study treatment. For device trials, a clinical engineer from the device company will check your device and may reprogram it.
Final Study Visit
At the final visit, you will complete your last set of assessments and be exited from the study. If you have any ongoing side effects, the study doctor will provide ongoing care until they are resolved.
Read about what happens after a clinical trial here.
Understanding Clinical Trials - Blog Series
It is important to us that our participants feel comfortable throughout their clinical trials journey. We are continually adding informative blogs to our website to provide transparent access to information for study participants. We also publish a range of condition-specific information blogs.
Read the following articles or watch the video below to learn more about clinical trials.