Healthy Volunteers

Q: What shall I do in order to participate in a clinical trial?

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.

Healthy Volunteers for Clinical Studies

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.

For healthy volunteers

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.

For more information about healthy volunteers clinical studies, please contact us via phone.

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.

What shall I do in order to participate in a clinical trial?

What does a typical clinical trial include?

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.

How long do the clinical studies last?

How long does a study visit last?

What is a screening visit?

What are the potential risks?

What are the benefits of the clinical studies compared to the risks?

Am I eligible to participate in a clinical trial?

What if something wrong happens with me during the examination?

Is there a medically qualified person in case of emergency?

What should I do if I have a problem?

What will happen if I experience any side effects?

What precautionary measures are taken for my protection in a clinical trial?

May I continue taking my usual medicines during the clinical trial?

Can I continue seeing my primary care provider?

Should I get an HIV test?

Can I leave after the clinical trial has started?

Are there any specific requirements while I am at the clinical site?

What should I bring with me when I participate in a clinical trial?

Are volunteers allowed to bring cell phones with them, while participating in a study?

Will I be compensated for my participation?

Can I participate in more than one clinical trial?

What precautionary measures do you take at the clinical site regarding the COVID-19 pandemic?

Are there any recommendations for me as a participant in a clinical trial?

Are clinical trials conducted only in one country?

What is the location of the clinical site?

What is a clinical trial?

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:

Phase I

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.

Phase II

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.

Phase III

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.

Phase IV

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.

How do we recruit potential trial subjects:

from a paper or electronic database of people who have indicated their willingness to take part in a trial;
by advertisements in a newspaper or magazine, on a noticeboard in places such as a university or hospital, on the radio or television, on a website or through social media;
by word of mouth, or
by referral from another doctor.

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.

Additionally, they should be recruited only if they:

are capable of giving valid consent, and
have been fully and properly informed so that they understand: the nature and purpose of the trial, any risks, either known or suspected, and any inconvenience, discomfort or pain that they are likely to experience
that they can withdraw at any time and without giving a reason
that the investigator may withdraw them at any time if they do not follow the protocol or if their health is at risk.

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:

the types of IMP and their half-lives
the routes of administration of the IMP
the frequency and duration of exposure to the IMP
the procedures involved, and
the total volume of blood taken from the subject.

Subjects must not:

take part in more than one trial at a time

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:

counselling the subject
including warnings in the information leaflet and consent form
keep a register of their clinical trials and subjects who have taken part in them
contacting the GP
being vigilant when screening trial subjects, e.g., looking for evidence, such as needle marks on the forearm and low blood counts, that the subject may have taken part in a trial recently, and

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.

Informed consent can be sought by the investigator or a delegate (doctors, healthcare professionals, non-healthcare professionals with appropriate training). They must:

obtain the consent of subjects only after the EC has approved in writing the information and consent form
fully inform potential trial subjects before they agree to take part in the trial
give the subjects oral and written information that is free of jargon and is easy to understand
give the subjects enough time and opportunity to ask questions about the trial, answer their questions accurately and honestly, and ensure that they understand the answers
ensure that neither the investigator nor other staff coerce subjects to take part or continue to take part in the trial
give the subjects, in writing and after approval of the EC, any new information that might make them change their mind about taking part in the trial, and
ensure that the subjects, and who informs them, sign and date a consent form, and are given a copy.

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

The investigator should judge trial subjects suitable on the basis of exams, such as:

a medical history and examination
medicines taken within a set period before the start of the trial
a 12-lead ECG
safety tests of blood and urine
tests for drugs of abuse – such as alcohol, cannabinoids, cocaine, morphine, benzodiazepines, barbiturates and amphetamines
tests for HIV, hepatitis B and hepatitis C
pregnancy tests in women capable of having a child and at risk of becoming pregnant
trial-specific tests, such as 24-hour ambulatory ECG, echocardiogram, lung function tests, kidney function tests and genetic tests
for IMPs that affect the immune system: tests to exclude active or recent infections, such as tuberculosis and Genito-urinary infection, and willingness not to travel to countries for which vaccinations are intended or that present a higher risk of infectious diseases during the period that the IMP may be active, and
information from the General Practitioner.

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 inform the GP that their patients have agreed to take part in a trial and should ask if their patients:

have or have had any relevant illnesses
are taking or have recently taken any medicines
have taken part in another clinical trial recently.

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:

asking subjects about adverse events;
medical examinations;
measuring vital signs such as heart rate and blood pressure;
safety tests of blood and urine;
continuous monitoring of variables such as the ECG and pulse oximetry, and
trial-specific tests, such as lung function tests.

The clinical trial protocol should include information on follow-up requirements. For example, the investigator will follow up:

all subjects after their last dose of IMP, for a period which is indicated in the protocol, depending on the IMP and the trial;
subjects with adverse events, including clinically-relevant abnormal laboratory results, until they have resolved or it is clear that they are resolving, and;
subjects who withdraw or are withdrawn from a trial, as if they had completed it, providing they agree.

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.