Complex Medical Procedures
In clinical drug development, there has been an increasing complexity of New Chemical Entities (NCEs) and Investigational Medicinal Products (IMPs), their delivery methods, and procedures used to comprehensively assess their efficacy and safety. Advances in drug development for rare diseases have contributed to this complexity, as they often require specialized routes for drug delivery and methods for the assessment of drug efficacy.
As Phase 1 clinical trials are the first stage of drug development that collects data on the safety, tolerability, pharmacokinetics, and pharmacodynamics of NCEs in humans, their design and execution are particularly challenging. To successfully perform and complete clinical drug development programs, a variety of different procedures for drug delivery and testing, including complex medical procedures, are employed.
Complex medical procedures can be used in a variety of clinical drug development contexts, including to measure the levels of an NCE in tissues or biofluids, to facilitate dosing, or to investigate the pharmacodynamic effects of an NCE. Working with an experienced and innovative clinical research organization (CRO) with the know-how to perform complex medical procedures while ensuring patient safety can greatly contribute to the successful completion of clinical drug development programs, including Phase 1 clinical trials.
Comprehensive Phase 1 Clinical Trials and Complex Medical Procedures at BioPharma Services
BioPharma Services is a full-service, complex medical procedures CRO with niche expertise in Phase 1 clinical trials. We can perform a wide range of complex medical procedures that can facilitate both the delivery of and testing for NCEs. At BioPharma Services, complex medical procedures are performed by both in-house physicians and external specialists affiliated with our clinic, with all physicians being certified by the Canadian College of Physicians and Surgeons and in good standing. We follow the best practices of the industry and perform all procedures under Good Clinical Practice (GCP) conditions. As an experienced Phase 1 CRO, we set study volunteers’ safety as our utmost priority. Moreover, we have successfully recruited study volunteers even for procedures viewed as invasive or unpleasant and ensure that they are carried out in a manner that minimizes discomfort.
Complex medical procedures routinely conducted at BioPharma Services include lumbar punctures, intraperitoneal injections, muscle biopsies, and ultrasound examinations. In addition, we continue to work with our clients to develop novel procedures for drug delivery and testing that are aligned with the needs of their drug development programs.
Our Complex Medical Procedures
Lumbar Punctures
Despite being relatively invasive, lumbar punctures (spinal taps) with cerebrospinal fluid (CSF) draws have found numerous applications in clinical drug development in the central nervous system (CNS) space and can aid in the selection of drug candidates for clinical development.
- Our team has successfully used lumbar punctures with CSF draws in several different contexts:
- To measure the CSF level of an NCE, which indicates the extent of its passage through the blood-brain barrier (BBB) and entry in the CSF, and ties into BBB passage testing.
- To use the concentration of an NCE in the CSF to help predict its unbound concentration in the brain, as CSF can serve as a surrogate for CNS exposure to an NCE.
- To perform specialty dosing in the CNS space.
- To investigate the effects of an NCE on biomarkers in the CSF compartment, providing information regarding the pharmacodynamic effects of an NCE.
At BioPharma Services, lumbar punctures are performed by experienced anesthesiologists, whose expertise helps ascertain the safety of study volunteers. Our proficient medical and scientific teams can provide guidance on the inclusion of lumbar punctures into clinical trial protocols, including the timing of CSF collection and number of lumbar punctures. BioPharma Services has established the necessary infrastructure required for the safe performance of lumbar punctures, such as the setup of specialized procedure rooms with hospital-quality sterility. We have also implemented all technical advances in the procedures for lumbar punctures to minimize study volunteers’ discomfort.
Even though there are still negative attitudes towards lumbar punctures that may hinder the recruitment of study volunteers for clinical trials, our team has been consistently successful with patient recruitment for the procedure. We have conducted lumbar punctures in various study populations, including both elderly cohorts and younger healthy populations.
Intraperitoneal Injections
For Intraperitoneal injections, we have found applications in drug development as a reliable method for the intraperitoneal delivery of NCEs for several medical conditions, including antibiotics for peritonitis and chemotherapeutics for intra-abdominal malignancies.
Why BioPharma Servicers is different:
- Our team has successfully utilized intraperitoneal injections as a novel method for ultrasound-guided drug delivery and dosing intraperitoneally or directly in the small intestine under sterile conditions.
- At BioPharma Services, intraperitoneal injections are performed by interventional radiologists, whose expertise helps assure the success of the procedure and the safety of study volunteers.
- We have assembled all required specialized equipment for intraperitoneal injections and have set it up in a specifically designed for this purpose procedure room.
- The fact that we perform intraperitoneal dosing onsite allows us to have greater flexibility in designing study protocols than CROs performing the procedure in hospital settings. This, in turn, helps us ascertain that all other aspects of the study protocol are also designed and performed in an optimal manner.
Our team can not only technically perform intraperitoneal injections but can also aid with the design of clinical trial protocols including intraperitoneal drug delivery, taking into consideration factors that may affect the pharmacokinetics of an NCE, such as the peritoneal surface area, time of contact, inflammation, and blood flow.
Muscle Biopsies
Muscle Biopsies are an invasive procedure that plays a role in the clinical drug development of NCEs for the treatment of neuromuscular disorders.
BioPharma Services has successfully performed muscle biopsies for several distinct indications:
- To determine whether an NCE has reached the biopsied muscle and to obtain pharmacokinetic data on it.
- To examine the pharmacodynamic effects of an NCE in the muscle and to gain insight into its mechanism of action.
- To obtain information that can aid in dosing decisions.
Muscle biopsies are performed by several of BioPharma Services’ investigators under the guidance of orthopedic surgeons, who have trained and continue to supervise our team. Despite the invasiveness of the procedure, we have successfully obtained muscle biopsy samples in all studies we have conducted. Our team has acquired the latest, state-of-the-art muscle biopsy devices, which function as vacuum suction instruments and are very user-friendly.
We are able not only to collect muscle biopsy samples, but also to process and stabilize them for further analysis. Since muscle biopsy samples require rapid processing, our expertise in this area is key for the delivery of reliable data.
Ultrasound Examinations
Ultrasound examinations are, among other imaging techniques, have been used as a non-invasive tool to gain insight into the in vivo effects of NCEs.
We have implemented the use of ultrasound examinations for several different purposes:
- To guide intraperitoneal injections and ensure they are carried out in a safe and effective manner.
- To perform echocardiograms and cardiac stress testing in collaboration with a third-party provider with a quick turnaround time.
- To aid in the assessment of the tumour response to chemotherapeutic drug candidate in patients with prostate cancer.
At BioPharma Services, all ultrasound studies are conducted in collaboration with a radiologist who interprets the study results. In addition to ultrasound examinations, BioPharma Services also offers other imaging services, such as positron emission tomography.
Establishment and Implementation of Novel Complex Medical Procedures
BioPharma Services can not only perform routinely established complex medical procedures but can also develop novel procedures that are aligned with the specific needs of our clients’ drug development programs.
- Our in-house medical and scientific teams have the know-how to assess risks, design and implement novel complex medical procedures, and prepare all necessary documentation to support the studies.
- We have also established a network of external collaborators and specialists who carry out some of the procedures, provide guidance on the implementation of others, and train our staff.
- BioPharma Services has put in place the necessary infrastructure and equipment for complex medical procedures, which gives us the opportunity to readily modify the procedures in alignment with the specific needs of our clients’ drug development programs.
- Our multidisciplinary team takes a customer-centered approach and discusses in detail the goals and specific needs of each clinical drug development program with our clients. Thus, we can modify complex medical procedures or establish new approaches that align with the sponsors’ requirements.
If you are looking for a full-service, complex medical procedures CRO with an innovative mindset and extensive expertise, contact us today. Our capabilities, services, and Phase 1 expertise enable us to competently support even the most comprehensive drug development programs requiring the implementation of complex medical procedures, while ensuring the safety of study volunteers. In addition, we are always ready to take on new challenges and start with the specific needs of our clients’ drug development programs to work collaboratively on fulfilling them. Talk to us to come up with new ways to perform complex medical procedures that address the needs of your drug development program.
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