Mohammed Bouhajib, VP
Based in the Greater Toronto Area, PMRI has been conducting early phase clinical trials in healthy volunteers, patients, and special populations, with unparalleled and uncompromised quality over the last 23 years. “Our reputation has been built on the principles of science, integrity, and reliability of the results,” says Mohammed Bouhajib, the Vice President, Laboratory Operations at PMRI. To date, the company has completed over 5,000 clinical trials and over 600 validated methods allowing them to develop extensive experience and expertise through the spectrum of drug development.
It has always been a challenge for pharmaceutical companies to develop highly variable and unstable drugs, and progress from the clinic phase to the bioanalytical results right through to regulatory submission and approval. The inhalation drugs are one of those categories of drugs that represent a challenge for pharmacokinetic (PK) studies due to the high risk of sample contamination and the low systemic absorption which require ultra-sensitive and reproducible methods to generate reliable data. “Method development is conducted using Quality by Design (QbD) principles to identify and prevent potential factors that may affect the integrity of study sample analysis. Our methods are validated in accordance to national and international guidelines,” informs Bouhajib. In addition, extra measures are taken based on science, PMRI’s experience, and expertise to ensure the robustness and ruggedness for reliable output of data which will stand the test of time. The organization foresees potential issues that may affect the integrity of the data. By conducting extensive experiments during research and development, and validation using authentic reference standards, they eliminate any source of bias such as back conversion of the metabolites (glucuronide, sulfate, N-oxide etc.) or isomer metabolite that may interfere with the analyte of interest if not chromatographically separated. Taking a top down approach and operated by a dedicated team of highly qualified scientists with unique experience and expertise, PMRI focuses on the integrity, reliability and validity of data and prides on its proven quality, scientific integrity, flexibility, rapid turnaround and a unique client-focused approach.
“Over the last few years, global regulatory agencies are encouraging the use of electronic data capture systems to capture and document the laboratory information.
Our reputation has been built on the principles of science, integrity and reliability of the results
PMRI is in the forefront of the industry by internally developing and validating integrated applications to our unparalleled Laboratory Data Management System (LDMS). We provide full electronic data capture and reporting in full compliance with global guideline,” mentions Bouhajib. PMRI’s bioanalytical laboratory continuously focuses on new technology to improve and optimize all operations through its proprietary LDMS.
LDMS is an integral part of PMRI’s laboratory operation to track, document, and generate the final bioanalytical data report using electronic data capture from the sample processing in their clinic to the final reported results. LDMS capture electronically all operations in the laboratory with unparalleled precision and sophistication, and it is compliant with the FDA CFR Part 11 with full audit trail. What Sponsors need is a full service contract research organization (CRO) that can produce high quality data with its developed processes, techniques, and expertise.
PMRI has routinely and successfully been audited by FDA, EMA, MHRA, AGES, Health Canada, ANVISA , GCC and the World Health Organization (WHO). Mohammed Bouhajib They have 360 beds in 6 self-contained clinics, a state-ofthe- art bioanalytical lab with 24 LC/ MS/MS instruments, an in-house organic lab for stable isotope internal standard and metabolite synthesis. In addition they offer full scientific and pharmaceutical regulatory affairs services.
Throughout the years PMRI has worked with Sponsors to successfully develop inhalation products that can be highly challenging from the clinic phase to the final bioanalytical results. There have been many occasions where PMRI performed “rescue studies” for Sponsors who have conducted multiple clinical trials, for the same product, and due to circumstances other than the formulation the outcome was not favourable. PMRI has identified key success factors and ensure they are considered in the clinical trials they conduct. With the same dedication to improve the quality and reliability of the data, PMRI is in the process of validating and implementing a newly developed in-house software for the clinical operation this year with full interaction and information sharing with LDMS and Pharmacokinetics (PK). “For the future, our aim is simple: continue the software development and improvement to cover the entire operation within PMRI, (completely paperless) as the advantages are multi-fold: cost efficiencies, faster turn around, curtails human errors, and last but not the least offers transparency and constructability of the entire trial” concludes Bouhajib.