Clinical Study: 36676 Thank You

Clinical studies play an important role in the medical and scientific fields to help understand various medicines and their impact on the body, especially in treating illnesses or diseases.

The design of each study varies depending on the type of research being conducted. All clinical studies for new medicines go through several phases to ensure safety, effectiveness, and correct administration. These phases help determine whether the medicine is safe to use, works for its intended purpose, and how and when it should be given.

Simbec-Orion operates as a Phase I clinical unit, where potential treatments are tested on healthy volunteers, and data is collected to determine the safety and tolerability of the drug. This data is later used for testing the drug on volunteers who suffer from a particular medical condition during later stages.

To participate in the study, volunteers need to meet certain requirements, such as age, gender, BMI (Body Mass Index), and potentially undergo other medical assessments to ensure their safety. It’s important to note that we also conduct studies on people diagnosed with Asthma, Diabetes, COPD, and Parkinson’s’, so we recruit not only healthy volunteers but also those with these conditions.

The payment for completing a study is classed as an inconvenience payment and is based on the overall commitment required to participate fully.

Due to ethical laws, subjects must voluntarily be willing to participate in our studies. Our payment for completing the study is purely an inconvenience payment for those who need to take time away from daily and lifestyle commitments. In addition, it is based on the number and level of procedures/assessments involved in each study.

As we are a phase 1 unit, we are at the first stage of any potential treatments. Due to this, we are not aware of how medications might affect or interact with you or the study at this stage. Therefore, for the majority of studies, you will be required to refrain from taking any medication or supplements while participating in the study, as well as prior to and after the completion of the study. This requirement will be study-specific, and you will be made aware before participating.

You do not need to be of non-childbearing potential for all studies.

However, a study sponsor (Pharmaceutical or Biotech company) may require this as part of the study inclusion-exclusion criteria to ensure a female is not capable of becoming pregnant while on or after study completion.

For the majority of our Phase I studies, there will be a requirement for one of our Research Physicians to review your past medical history.  This is to ensure that you are safe to participate and that there are no indications or episodes documented in your medical history report stored and recorded with your General Practitioner (GP). By accessing this report, we can determine your eligibility based on the requirements for our studies. We will ask for your consent to request this information, and we will not request any information from your GP without your consent.

Inconvenience payments are available once you successfully complete the study, and it is mentioned in the consent form, which you will have signed before undergoing any study-specific screening or procedures.

Successful completion includes any additional follow-up visits or repeat samples that may be required. Payment may also depend on your adherence to study restrictions and compliance during the study duration. The Enrolment Services team is responsible for processing your payment. Once the team receives evidence that you have completed the study, your payment will be processed and may take between 1 and 2 weeks to complete.

Before a clinical study of a new medicine can commence in the UK, a government agency known as the Medicines and Healthcare Products Regulatory Agency (MHRA) must review and authorize a formal clinical study application (CTA) from the pharmaceutical company and the Clinical Research Organization (CRO) involved, such as Simbec-Orion.

The MHRA also conducts regular inspections and audits of research units where studies are conducted to ensure that they are conducted in accordance with good clinical practice and meet all the requirements of a research site to run studies and research in a safe and appropriate manner. Simbec-Orion’s Phase I Pharmacology Unit is part of the MHRA Phase I Accreditation Scheme in the UK.

Once you have attended a screening appointment, our doctors will carefully review your screening data, procedure results, medical history, and laboratory results. After this review, a member of the Enrolment team will contact you to let you know if you have been selected to participate in the study.

Please note that we are required to invite more volunteers than needed for each cohort. This is done to ensure that we can keep the study timelines on track and have a safety net in case some volunteers fail to attend for study admission or if any volunteers fail on any procedures.

It’s important to understand that being invited to participate in the screening process doesn’t guarantee that you will be dosed in the study. However, you will receive an inconvenience payment for the time spent at the unit, even if you are not selected to participate.

Every study is unique, and as a result, potential side effects are specific to the particular study. These side effects will be clearly outlined in the Information Consent Form, which is sent via email when you are invited to participate. At the screening appointment, you will have ample time to check and understand the potential side effects or restrictions you may need to adhere to. you will also have the opportunity to talk to the medical team and ask any questions before providing consent to participate.

Our consent forms provide a detailed explanation of the potential side effects of any study. After the study, you must attend a follow-up session with a full medical assessment and necessary procedures, similar to those at the screening. Throughout the stay, you are closely and carefully monitored and have direct access to our trained clinical team if you need assistance. If you are off-site, you can reach our on-call medical team of trained research physicians (doctors) for medical support.

We invite all volunteers to bring their own entertainment items such as laptops, computers, game consoles, books, etc. to keep themselves occupied during their stay. We provide free Wi-Fi throughout the unit so you can always stay connected. The wards have TVs and a pool table for use. There is also a recreational lounge for you to use, equipped with sofas, desks, chairs, and a variety of board games or books.