BioPharma Relocates To Expanded Clinic Facility in St. Louis, Missouri
BioPharma Services, Inc. (BioPharma) is excited to announce the relocation of their US based clinical facility to a new location in the greater city of St. Louis, Missouri.
The ongoing pandemic has compelled BioPharma to re-evaluate our clinical operations in the city of Columbia MO, a community that has embraced BioPharma’s operations and allowed us to expand our clinical footprint in the USA. In this new climate of physical distancing and travel restrictions, minimizing travel and reducing the risk of community transmission will be of paramount importance. BioPharma has therefore made the strategic decision to continue its US operations at a new clinical centre located in the larger city of St. Louis. This move will serve to further safeguard our stakeholders including our sponsors, subject volunteers and staff members.
The new centre, located in Creve Coeur, Missouri, is the former site of St. Louis Clinical Trials (a subsidiary of Evolution Research Group). Located within 15 minutes of St. Louis’ Lambert International Airport, BioPharma’s US centre will allow for quick and easy access for our sponsors, monitors and visitors and minimize the distance of travel for the majority of our subject volunteers who reside in the city of St. Louis. The 2-story, 25,000 square foot clinic facility opened on June 1st with 100+ beds.
Our US operations will continue to be led by Andrew Janis, Director of Clinical Operations, BioPharma USA. We are also pleased to announce and welcome Dr. Artan Markollari, M.D., to our team as lead Principal Investigator of our US centre. With over 21+ years of experience in Family Medicine, Dr. Markollari joined the clinical research community over 5 years ago serving as an Investigator for Phase I clinical trials and Bioequivalence studies in the St. Louis area. The US site will continue to operate under the same umbrella of BioPharma SOPs that has allowed us to host 4 FDA inspections at our Columbia site with zero Form 483s being issued. Additionally, our operating guidelines and procedures have been further enhanced with rigorous protocols that have been implemented in response to the COVID-19 pandemic.
While COVID-19 paused our clinical operations in the US, our Toronto, Canada site has remained operational throughout the last 12 weeks when self-isolation mandates were first enforced. Despite the challenging environment, BioPharma continues to offer world class clinical trials to support drug programmes including Phase I, Bioequivalence, Bioanalysis and Human Abuse Potential studies. Exacting new SOPs combined with additional in-house working guidelines and procedures, has allowed the Toronto site to overcome the daily obstacles presented by the COVID-19 pandemic to continue providing critical and essential research trial needs. With this experience in hand, the Executive and Management teams at BioPharma are confident these same working principles will be successfully executed at our US clinical centre in St. Louis.
Anna Taylor, Executive Vice President Business Development, noted “Our team here in the US knows the St. Louis clinical landscape very well. This presents a unique opportunity for BioPharma to further grow and build on our reputation of agile client focused service. Our responsive team is ready to provide aggressive study start-up, innovative solutions and quality execution for all research needs”.
Renzo DiCarlo, CEO, further commented, “I am excited about our growth in St. Louis and the expansion of our Phase I capabilities in the US. Our team’s performance during these turbulent times has been exemplary and I am certain that our St. Louis site will well complement our outstanding record of clinical trial excellence”.
About BioPharma Services Inc.
BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Data Management and Medical Writing.
What are early phase clinical trials?
Clinical Trials are divided into 4 phases. Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.
The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects. Phase 1 trials are conducted in healthy volunteers.
Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.
What is a clinical trial?
A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective. In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.
What is an investigational drug?
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:
- If the drug is safe and effective.
- How the drug might be used in that disease.
- How much of the drug is needed.
- Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?
In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.
Should I expect to experience any side-effects while doing studies?
As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.
Will I be compensated for doing a clinical study?
Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).
Are food and accommodation provided over the course of the trial?
Food – Clinical trials are conducted in a controlled setting which means that all food is provided and trial volunteers receive standardised meals. Individual meal plans or meal preferences cannot be provided. If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial. Please contact us to discuss any food issues.
Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender. Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.
What is the length of a study and do I have to complete all the visits?
Details of the duration of a study can be found on the Volunteer Hub.
What is informed consent and how is it carried out?
Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF). The ICF describes the clinical research study and the nature of the investigational product to be used, including:
- Your rights and responsibilities as a study participant.
- What you will be asked to do during study participation.
- The potential risks that you should be aware of.
During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff. You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.
Can I bring my own food?
All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video
When do I receive compensation for taking part in a study?
You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)
Where will I sleep during the clinical study?
We provide a clean, safe socially distance sleeping environment, in a dormitory of hotel room style. Watch video
What COVID-19 precautions are you taking?
The safety of our volunteers is a top priority. Learn more about the measures we are taking to create a safe environment for you.
Can I bring my own device?
Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.