Special Populations & Services
Special Patient Populations in clinical trials include groups with unique characteristics, such as those with rare diseases, genetic disorders, or specific demographic factors. These populations often require tailored recruitment strategies and specialized study designs to ensure valid and reliable results. With our enhanced recruitment capabilities, we can effectively support your next drug development project.
BioPharma’s Expertise in Special Services & Procedures
BioPharma Services is a full-service CRO specializing in early-phase development with expertise in diverse therapeutic areas, including cardiovascular diseases and central nervous system (CNS) disorders. Our specialization in special patient populations ensures that we meet the unique needs of these groups during clinical trials. Our award-winning medical and scientific team can efficiently perform special services and procedures in-house, streamlining the drug development process. We have extensive know-how in the recruitment process and have established an extensive database of potential study volunteers, including individuals from special patient populations.
Proficiency in Cardiovascular Services
Cardiovascular clinical trials may require the use of special procedures and may face difficulties enrolling study volunteers from sufficiently diverse populations. Thus, working with an experienced clinical partner may be key to the success of their design and conduct. Notably, clinical trials advancing the early phase development of NCEs for cardiovascular diseases have represented 16% of BioPharma Services’ portfolio. To competently support our clients’ cardiovascular clinical drug development programs, especially for special patient populations, we have established:
- A proficient, multidisciplinary, in-house medical and scientific team with expertise in cardiovascular diseases
- A network of external collaborators qualified to perform complex cardiovascular procedures
- A partnership with an interventional cardiologist, whose expertise enables us to conduct intraperitoneal studies
- A state-of-the-art Phase 1 clinical facility that is equipped for ongoing safety monitoring of study volunteers
- The ability to conduct echocardiograms and cardiac stress testing in a timely manner via an external collaboration with a third-party provider
- Comprehensive guidance and support in cardiovascular clinical trial design, including the selection of endpoints and biomarkers
Expertise in CNS Services
Clinical trials in the field of neuroscience can be particularly challenging, as understanding of the mechanisms underlying CNS disorders is less advanced than in some other organ systems, and there is a scarcity of disease biomarkers. Early phase development for NCEs tested for their therapeutic potential in CNS diseases also constitutes a large part of BioPharma Services’ portfolio (14% for studies on neurological diseases and 11% for studies on psychiatric disorders). Our know-how in the field of CNS drug development, particularly for special patient populations, includes:
- Extensive experience with clinical drug development programs on compounds intended for use in various CNS disorders, such as major depressive disorder, anxiety disorders, Parkinson’s disease, and Alzheimer’s disease. NCEs that our team has investigated for their therapeutic potential in CNS disorders include antidepressants, stimulants, analgesics, anesthetics, anticonvulsants, and Antiparkinsonian agents.
- Expertise in early-phase clinical trials on NCEs with human abuse potential (HAP) that require unique and complex study design, execution, and analysis, including studies assessing abuse-deterrent formulations (ADFs).
- Know-how in the design and conduct of clinical studies on psychedelics, which are being actively investigated for their therapeutic potential in psychiatric diseases, including anxiety disorders and major depressive disorder.
- An experienced team of physicians and scientists with CNS expertise, who can identify, manage, and oversee possible drug-dependence and withdrawal symptoms and provide overall safety monitoring.
- State-of-the-art clinical facilities and an in-house laboratory for bioanalysis.
- Proficiency in the implementation of pharmacodynamic and cognitive endpoints and biomarkers.
Ability to Conduct a Wide Array of Complex and Diagnostic Procedures
BioPharma Services has put in place the necessary expertise and infrastructure to conduct in-house a wide array of complex and diagnostic medical procedures. They include:
Lumbar Punctures
Lumbar punctures are carried out by proficient anesthesiologists in specialized procedure rooms with hospital-quality sterility. Lumbar punctures can be used to measure the cerebrospinal fluid (CSF) levels of novel NCEs, to predict their concentration in the brain, and to perform specialty dosing in the CNS space. In addition, lumbar punctures can help reveal the effects of an NCE on CSF biomarkers. Nevertheless, we are also developing assays to determine the effects of NCEs on biomarkers in peripheral blood mononuclear cells (PBMCs) as a less invasive alternative.
Various Diagnostic Procedures
Various diagnostic procedures, such as endoscopies and prostate examinations, can be conducted by BioPharma’s experienced investigators and external collaborators.
Ultrasound-guided Intraperitoneal Drug Delivery Studies
Ultrasound-guided intraperitoneal drug delivery studies, performed by interventional radiologists in an in-house procedure room designed specifically for this purpose. Some of the indications, in which these studies can be employed, include the administration of antibiotics for peritonitis and chemotherapeutics for abdominal tumors.
Muscle Biopsies
Muscle biopsies are performed by our investigators under the supervision of orthopedic surgeons. Muscle biopsies are used to collect pharmacokinetic and pharmacodynamic data on the effects of NCEs in muscles and can aid the development of novel therapeutics for neuromuscular disorders.
Design and Implementation of Novel Special Services and Procedures
The design and implementation of novel special services and procedures that address the specific needs of our clients’ clinical drug development programs. Our multidisciplinary team of physicians and scientists work individually with study sponsors to develop and establish procedures that align with the particular goals of their clinical trials.
Challenges Associated with Special Services and Populations
Historically, specialty procedures have typically been performed in hospitals to comply with strict regulatory requirements, but this has increased the logistic complexity of clinical studies and extended their duration. In contrast, BioPharma Services, which has the competence and infrastructure to perform specialty services and procedures in-house and to continuously monitor study participants, can streamline clinical trials and shorten study timelines.
Clinical drug development programs, especially those targeting special patient populations, should be inclusive and should enroll study volunteers with diverse backgrounds. However, planning clinical trials involving individuals from special populations requires additional ethical and regulatory considerations to ensure their safety. CROs with recruitment expertise and established databases of potential study volunteers can help overcome these recruitment and retention difficulties.
A Large Database of Study Volunteers, Including Special Populations
BioPharma Services has established an extensive recruitment database of approximately 65,000 potential study volunteers, including both normal healthy volunteers and special patient populations. Our database encompasses:
- Normal healthy volunteers with study-specific inclusion and exclusion criteria
- Individuals with obesity and/or type 2 diabetes
- Post-menopausal and surgically sterile females
- Patients with CNS diseases, including major depressive disorder, anxiety disorders, Alzheimer’s disease, and other dementia types
- Elderly individuals
- Individuals with diverse ethnical and racial backgrounds, enabling the performance of ethnocentric studies
- Recreational drug users, including individuals consuming cannabinoids, stimulants, opioids, and hallucinogens
Well-established Recruitment Services
BioPharma Services has extensive expertise in recruiting special patient populations for clinical trials across various therapeutic areas and populations. Our strengths in study volunteer recruitment include:
- Easy access to diverse study populations facilitated by our central location in Toronto, Canada
- A competent and efficient subject recruitment call center and screening unit that streamline the volunteer recruitment process
- Access to a large population of pre-screened (study-specific) participants
- Assistance with the development of a comprehensive recruitment and retention plan, aligned with the specific needs of each study
- A state-of-the-art clinical research facility, offering support and accommodations for normal healthy volunteers, patients, and their caregivers on an as-needed basis
- Regarding the safety of study volunteers as an utmost priority and providing ongoing and intensive safety monitoring by highly qualified and ALCS-trained personnel
- Strict adherence to ethical subject recruitment practices set forward in the guidelines of the International Conference on Harmonization (ICH) and the World Medical Association
If you are looking for a full-service, early-phase CRO with expertise in the recruitment of special patient populations and in-house performance of special services and procedures across diverse therapeutic areas, contact us today. Our multidisciplinary team, state-of-the-art facilities, and a large database of study volunteers position us perfectly to design and conduct comprehensive clinical drug development programs, involving the recruitment of individuals from special patient populations and the performance of special services and procedures.
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