Convex Clinical Research Institution constantly maintains and develops a database of healthy volunteers ready to participate in clinical trials and medical device investigations. On a weekly basis we communicate with our study participants to ensure their future interest in participating within our clinical projects. With a database of over 1800 potential healthy volunteers we meet our sponsors’ expectations of recruitment strategy and study goals. We reach healthy volunteers recruitment within timelines given by our sponsor companies. We focus on excellent communication with our participants, which we believe, it is the key factor for successful study subject recruitment and retention. Our clinical research team helps build relationships with participants and ensure their needs and requirements are met. On a project basis we gather healthy volunteers’ feedback about their experiences and improve our services so that we improve their hospital stay with us. During the entire course of the study, volunteers’ satisfaction is our primary focus. Our healthy subject database includes over 1800 non-smoking subjects. It consists of students and young people representing 84 % of our participants and a second group of 55+ aged (postmenopausal and elderly) participants. Please contact us with a request and we can share more information on our healthy subject population.
As a healthy volunteer, you have the opportunity to participate in one of our clinical research programs that are conducted at Convex Pharmacology unit.
In order for this to happen you must meet certain inclusion criteria. Before any start you need to be aware of that you have no acute or chronic medical conditions and you have not participated in any other clinical studies in the last 6 months
If you meet these 2 basic criteria please contact our specialist and discuss more on your potential participation in the clinical studies that are currently under processing.
In order to proceed, you will need to go through several stages of assessment:
Stage 1: Introducing the participant to the clinical study. During this stage, the participant receives basic information about nature and progress of a clinical study including information on: drug under investigation, potential risks of participation, study duration, procedures and etc.
Stage 2: Informed consent. You are provided with an informed consent in a language that is understandable to you, which contains full information about your participation during the course of the study.
Stage 3: A detailed discussion with the principal investigator about your participation. During this discussion with a clinical investigator, you will be encouraged to ask any questions that you may have and receive clarification regarding your participation. In case you have missed an important question, it can be discussed with the clinical study investigator at a later stage before ICF is being signed. It is advisable to discuss your participation with your family doctor or your family members. If you wish to proceed you will be invited to the next stage of the process:
Stage 4: Signing an informed consent. In the presence of the medical team members, you and a principal investigator will sign and date the informed consent. Please note that you have the right to withdraw your consent and to terminate further consent at any time without giving a specific reason.
Stage 5: A complete examination to assess your health. After finalizing your informed consent and if you are willing to further participate, you will proceed to a full medical examination. A blood sample will be taken from you for testing. If you have been assessed by the research team as a healthy volunteer and meet all criteria for inclusion in a clinical study, you can move forward.
Being a participant, it is completely normal to be concerned about your safety. That is why here at Convex Clinical Research Center, the welfare of our participants is our top priority. The initial documentation for every clinical trial we undertake is submitted to the Bulgarian Drug Agency and to the Central Ethics Committee. As independent regulatory bodies they review the available information and ensure that each trial maintains the highest levels of safety before giving their approval. Prior to any on-site assessments or screening procedures, you will be asked to sign an Informed Consent Form to confirm that you completely understand what is expected of you as a clinical trial volunteer. One of our physicians/ investigators will be assisting you in the process of signing and will give you the opportunity to ask any questions you may have about the clinical study, your safety and the possible side effects.
If you are interested in participating in a specific clinical trial, you can make an appointment to visit our clinical research site. We will give you more information about the clinical study and explain to you about its background and purposes. Sometimes we do this in small groups, and other times it is during a personal conversation. Either way your study doctor will answer any questions you may have. At this point, if you are still interested, you will carefully read and sign the Informed Consent Form. This document describes everything that will follow in the clinical trial, along with the potential risks and benefits. You will then be examined by a clinical investigator to make sure you are healthy and meet the other requirements for participation. This assessment may include basic tests and measurements such as medical status, body height and weight, blood tests, taking of urine samples, and other tests necessary to find out if you will be eligible for participation. This is called the “Period of screening” and is usually performed a few days before the “Period of dosing”. Our medical team will use them to decide if a clinical trial would be suitable for you. If you are eligible, you will be offered a place in the study.
Clinical trials are different and each of them requires a set of specific procedures and tests, but you will be fully informed about them prior the screening or before your inclusion in the clinical trial. Before the beginning you will be asked to come for a screening appointment, including a preliminary medical examination and a simple blood and urine test to ensure that you are suitable to take part. Before any assessments are carried out, you will be given all the details of the clinical trial and will be asked to sign an Informed Consent Form. After reviewing and signing the Informed Consent Form you will not be obliged to participate in any clinical trial and if you decide to participate in one of our clinical studies, you may withdraw at any time. In the course of an actual trial, it is very likely that you will be asked to give blood and urine samples at certain times during your stay. In addition your blood pressure and heart rate may be monitored periodically. Every clinical study follows a strict schedule of events. For example, you may be asked to abstain from food during night in order to prepare for the dosing of the investigational medicinal product, which usually happens in the morning. Dosing is primarily in a tablet form, but it may be in the form of an injection, liquid, patch or infusion. Prior to your discharge from any clinical trial, it is mandatory that you undergo a post-study blood test and medical examination. After your discharge by one of our doctors/investigators, you will be compensated for the inconvenience of each test or sample collection and for your time and effort to participate. You will receive the compensation only after the completion of the clinical trial. At Convex Research Center, we do our best to make your stay as comfortable as possible with a full range of free facilities: TV sets, books, magazines, electronic games, board games and WiFi at your disposal. If you do study, work or relax, there is a quiet room equipped with free WiFi access. We provide you with meals during your stay, although there may be certain restrictions on what you are allowed to eat. On request we can provide an alternative dietary menu, such as vegetarian meals, when allowed by the requirements of the clinical study.
Their duration varies. Some studies require only one or two weekends at a clinical research site, while other studies require longer periods – up to several weeks. Followed by additional visits for blood samples or follow-up visits.
The length of your visits depends on the specifics of the study. Most clinic visits last at least 90 minutes and can last up to several hours. Your first visit will be longer because we collect information about your medical history and discuss the clinical trial with you. The study team will let you know what to expect at each visit.
A screening visit is a key step towards your inclusion in a clinical trial. At this visit you will review the Informed Consent Form with members of the study team at the clinical site. The Informed Consent Form describes the details of the clinical trial, including your rights and responsibilities as a participant and any possible risks so you can decide whether you want to participate. The study team will answer any questions you may have. If you decide to take part, you will sign the Informed Consent Form and will then undergo the tests, procedures or assessments necessary for the study to confirm that you meet the criteria for inclusion in the clinical study. They may include blood tests, electrocardiograms (a test that uses sensors attached to the skin to check the rhythm of your heartbeat and electrical activity) and vital signs.
We submit each study protocol for review to the Central Ethics Committee consisting of members of the public, including medical professionals who are independent of the clinical site. The CEC evaluates each study protocol to determine whether it meets international regulatory guidelines and guarantees the safety and well-being of the volunteers. The CEC is there to protect your rights, safety and well-being. The committee reviews and approves all aspects of each study, including the type and dose of medicine you will be given, any tests that will be performed during the clinical study. Doses of medicines given to clinical trial volunteers are very carefully controlled.
Sometimes there may be side effects. Any known side effects will be explained to you before you decide whether or not to take part in the study for which you are eligible. These side effects are usually mild and may include headache and nausea. For your own safety, it is important to always inform us regarding all prescription and over-the-counter medicines and food supplements that you take.
The risks and benefits vary from study to study. Before participating, all the risks that we are aware of will be explained in the Informed Consent Form, which you must read very carefully and sign before your inclusion. You may benefit from the treatment being studied, although we cannot guarantee this. By the way our clinical staff will be there to attend to any concerns and to answer any questions you may have.
Each year we have over 600 people participating in our clinical trials, including healthy volunteers and patients of all ages and backgrounds. Each trial has its own individual inclusion and exclusion criteria, so although you may not be eligible for any of our current trials, you may be eligible for future trials.
During the screening visit, we may perform tests that are not normally done in a routine medical examination. For example, tests may include a heart test (electrocardiogram) or blood tests that measure the health of your liver. If we suspect that there is a problem, we will repeat the test to check the results. If we find a potential health problem, you will be referred back to your primary doctor with a copy of your lab results prepared by our staff.
Yes. The health and well-being of each volunteer is our priority. Qualified medical staff is always on call and a doctor is available around the clock.
Please note that if you choose to participate, you will be able to contact us 24/7 in the course of the clinical trial. During business hours you can call our clinical site and a clinical study assistant or study doctor will help you
You may experience side effects while participating in a clinical trial. The clinical study team will discuss with you what to expect and the Informed consent you sign will contain this information. The Ethics Committee will review the possible side effects in detail to ensure that the risks for you are minimal and that mechanisms are provided to manage the side effects. This includes providing Contact information and the place where you can seek help. In all cases you should follow the instructions in the Informed Consent Form regarding adverse reactions and use the contact information given there
A number of precautionary measures are taken to protect you and other participants in clinical trials, and attempts are made to minimise the possible risks. Some of the precautionary measures to protect clinical trial participants include:
– Review of the clinical trial documentation by the Central Ethics Committee prior to authorization of the clinical trial. The Ethics Committee ensures that highly qualified investigators conduct the clinical trial with Informed Consent Form that you can understand that the protocol is solid and that the risks are reduced to a minimum or appear reasonable compared to the expected benefits;
– Participant Informed Consent Form that explains in detail the clinical trial and its
expected benefits and risks, outlines the rights and responsibilities of participants, and provides all contact information for the clinical trial, including that of the EC;
– Supervision of the scientific and medical aspects of the clinical trial throughout the conduct of the trial;
– Good clinical practice guidelines to be followed;
– Regulations from the Bulgarian Drug Agency that must be followed. Investigators must conduct their clinical trials in compliance with the laws and regulations
It depends on the clinical trial. You will need to tell the clinical investigational team about all medications you are currently taking so they can decide if there is a potential risk of a negative interaction. They will let you know if you can continue to take your current medication or if the clinical trial is not suitable for you because of the intake of this medicine.
Yes, you will still be able to be seen by your regular treating doctor (this may be a family doctor), specialist, etc.) as well as by the clinical trial team during your participation in the clinical trial.
An HIV test is required for some studies. During the screening process you will be informed if you need to be tested for HIV or not.
Yes, you can choose to leave the clinical trial at any time – it depends entirely on your decision. Leaving the clinical trial will not affect your standard medical care you receive outside the clinical trial. The participation in clinical trials is voluntary. Although patients may be asked by the staff to participate in a clinical trial, it is up to the participant to make the final decision or to withdraw from the clinical trial. If you want to do so, then you will be advised what to do by the clinical study investigator.
Yes, we provide you with a list of the clinical site‘s safety and comfort rules for all volunteers. They include rules about smoking, alcohol use and caffeine, behavior and conduct. In addition, there may be rules that pertain to specific study. For example, you may have to eat all the food provided or refrain from physical exercises.
You should bring personal hygiene items for the duration of your stay. Please, do not bring food, drinks or cigarettes if it is a non-smoking study.
Cell phones are allowed, but if the phone has a camera, it must either be removed or covered with a protective band. No cameras are allowed at the clinical site. Cell phones must be turned off during the study procedures.
If you participate in a Phase I clinical trial (where the investigational treatment is being tested on healthy volunteers), you will probably not experience any therapeutic benefits. Herefore, you will be compensated for your time and for the inconvenience. The amount depends on factors such as length of stay, total number of visits, etc. All information is strictly given/ described in all details within the Informed Consent Form.
Yes, many of our healthy volunteers are eligible for different studies and work with us on multiple occasions. However, you cannot participate in more than one study at a time and there is a minimal waiting period between studies. This waiting period is known as the „washout“ period and can be several months, depending on the medicine being tested. In addition, if you are a blood donor, you will need to observe a minimal “washout” for blood donation, which will vary from study to study.
Additional measures have been implemented to protect our clinical trial participants and our team from COVID-19 infection . You will have your temperature checked and you will be tested for COVID-19 infection by a PCR test upon entering our clinical site. We have also included a mandatory use of masks and signs to maintain physical distance in the clinical site. There is also a sanitary staff responsible for the cleaning and disinfection of the building throughout the week.
The following things are recommended to do when participating in a clinical study:
– Keep all important documents, such as Informed Consent Forms;
– Take notes of important points to discuss, write down the medication schedule, and other information in a notebook that you also carry with you to the appointments;
– Make sure that you have your clinical study participant (subject) card;
– Maintain a calendar with your appointments and medication schedule;
– Make a list of key contacts – names and phone numbers – and keep it in an easily accessible place at your home.
You can sign up by calling +35929051970. The telephone assistant will ask you a few general questions about your current health status and medical history and will schedule a personal screening appointment if you qualify for the study you have chosen.
Clinical trials are often conducted in more than one country at the same time. So even though you are participating in one location, the data collected by you and others participating at that site may be combined with participants from many other sites around the world, all of whom are participating in the same clinical trial.
11A Sinanishko ezero, Sofia 1680, Bulgaria
Before a new treatment can be prescribed to a patient, there is a long way to go. It starts in the laboratory, with so-called preclinical studies, during which scientists carefully study the potential new medicine. If the results of these preliminary studies are promising, the clinical study process of the investigational drug begins, where its effects are studied on humans. These healthy volunteers may receive a specific treatment, a placebo, or no treatment at all, may undergo various assessments and come for visits to the investigational site. Each clinical trial follows a carefully designed study plan, called a clinical trial protocol, which is approved by groups of medical professionals to ensure the participants’ health is safe. All clinical trials we conduct with our partners, comply with international standards and guidelines. Clinical trials are typically conducted in four phases:
This is the first time an investigational medicinal product will be tested on humans and often requires a small group of healthy volunteers – about 10 to 30 people. The aim is to find out how the potential medicine interacts with the body and whether there are any side effects. Initial doses are lower and are increased gradually.
The purpose of Phase II clinical trials is to find out how safe and potentially effective investigational medicine is for people with a particular medical condition. This phase often compares the investigational medicine to a placebo and usually involves approximately 100 to 200 participants. The purpose of these studies is to show whether the study has any effect on the specific medical status.
In clinical trials Phase III, the potential treatment is observed in a larger number of participants (several hundred or even several thousand). This is an important step in the development of a potential medicine, as it aims to collect more information on efficacy and safety in comparison to already approved treatments. This phase can last several years and can be conducted in many investigational sites all over the world.
Once the potential treatment passes the above described clinical trial phases and is successfully approved by the regulatory authorities, it becomes available for public use. Clinical trials Phase IV trials are conducted in „real life circumstances” rather than at a clinical site, and their purpose is to investigate the long-term effects that the treatment may have.
Most people at some point in their lives have taken or will take or are presently taking some form of medication. These medications have been developed through clinical trials, so every time we use a medicine, we benefit directly from these clinical trials that involve healthy volunteers and patients like you. The medicines we now take for granted were once new medicines and had to go through a series of clinical trials and tests before they were put on the market. In fact, the research of these medicines continues because the pharmaceutical companies seek to improve their formulation and function. Giving medicine to a healthy volunteer or patient provides information on the safety and tolerability of new medicines and how the body absorbs and excretes them. This can be tested, for example, by taking samples of blood and urine samples, measuring blood pressure and performing an ECG (monitoring your heart rate) at different times of the day. Have you thought about how the doctor knows how often you should take the medicine? Again, this information is obtained from measuring the medication in the participants’ blood. This is done by taking blood samples over a period of time and then measuring the amount of the medicine in each sample. Clinical trials are vital to help and prevent major diseases and conditions, so we need your support to ensure clinical research continues to develop medicines and treatments of tomorrow.
All study-specific advertisements must be approved by a EC. The Clinical Trials Directive guidance document on EC applications give advice about advertising for subjects for clinical trials. Advertisements should say that the trial involves research and that the advertisement has been approved by a EC, and should give a contact name and phone number and some of the selection criteria. In addition, advertisements may give the purpose of the clinical trial, where it will take place and the name of the company or institution carrying it out.
However, advertisements must never over-stress payment, use EC or BDA approval as an inducement, name and promote the product, or claim that it is safe. To ensure consistency, in the advertising for Phase I studies should seek ethical advice on the procedures. Whatever the method of recruitment, subjects must be recruited of their own free will. They should not be made to feel obliged to take part in a clinical trial, nor should they suffer in any way if they do not take part.
At Convex we keep records of subjects who take part in their trials and avoid excessive use of any subject. The number of trials that a subject may take part in during any 12-month period will depend on:
Trial subjects must provide proof of identity before they take part in a trial and should be monitored and prevented from taking part in too many trials. The ways to ensure this are:
The inclusion of women as early as possible in drug development might be a valuable clinical strategy depending on the characteristics of the IMP and on its primary indication.
In the exploratory Phase I trials such as single and multiple ascending doses, women will typically be of non-child-bearing potential being subject to the standard inclusion/exclusion criteria for the trial to be conducted.
However, when a sponsor has decided to include Women Of Child Bearing Potential (WOCBP), particular considerations should be given depending on the speculated magnitude of human teratogenicity/fetotoxicity.
The written informed consent form and any other written information to be provided to subjects for an FIH trial present unique challenges to the author. The document must provide an interpretation of risk derived solely from pre-clinical data and knowledge of the pharmacological target in a way that is easily understood by a lay person. In the choice of site, the sponsor should check that the site has robust consent procedures in place, and should consider the PI’s experience in writing or reviewing informed consent documents.
Some specifics of the informed consent documentation for FIH clinical trials are different from those of later trials or later phase trials. For example, in most cases with FIH clinical trials, the written informed consent form is drafted by the unit staff rather than the sponsor, and it must contain the rationale in lay language for the start dose and the maximum dose.
The critically important information on the drug characteristics (pharmacological and toxicological) to support the start dose and the maximum dose should be provided by the sponsor who also bears a responsibility for the wording being chosen to be easily understood by a lay person. Otherwise, the elements of the informed consent discussion and the written informed consent form must comply with the Good Clinical Practice
Before subjects decide to have the tests for viruses and for drugs of abuse, the investigator must explain to them what will happen if one of the tests turns out to be positive.
Healthy subjects often have minor out-of-range results of safety tests of blood and urine, and minor variants of the ECG. Some CRAs/ medical monitors and auditors regard these as deviations from the protocol of a trial in healthy subjects. However, usually they have no clinical relevance and do not justify excluding subjects from a trial. A physician should decide their clinical relevance, and the protocol should allow for use of clinical judgment.
The investigator should ask potential trial subjects for permission to contact their General Practitioner (GP). Subjects who do not have a GP or do not want their GP to be contacted should be excluded from the trial unless there is a good reason to the contrary.
The investigator should ask the GP to reply in writing. The investigator must be able to justify including in the trial a subject whose GP does not give any information. Whether or not the GP responds, the investigator is ultimately responsible for making sure that subjects are suitable for the trial before allowing them to take part in it.
The investigator must assess the health of trial subjects throughout the trial and should withdraw any subject whose health is at risk. The methods should include:
The clinical trial protocol should include information on follow-up requirements. For example, the investigator will follow up:
|Data base of healthy subjects||Every year hundreds of healthy volunteers participate in our research programmes. Based on the length of the clinical study or subjects involvement the studies are paid differently.|
|Healthy subject||Any non-smoking person, over 18 years of age, who has no chronic or accute disease can freely register for further clinical assessments and participation into our clinical trial pipeline.|
|Clinical trial duration||A Clinical trial can vary between single ambulatory visit tomultiple site visits or from 24 hour site stay to 30 days of hospitalization. A study might have a long period of follow-up after the clinical trial treatment phase is completed.|
|Paid clinical studies||All clinical trials which enroll healthy subjects are paid. Reimbursement fee depends on many details over a study design, time participation and variety of clinical reserch procedures involved.|
|Clinical research center with phase I unit||Our research institution is build-up in a way to confort our research participants so that everyone can enjoy their time during the entire course of a clinical research study.|