GHP Q2 2021

38 GHP / Q2 2021 , Mar21639 BioPharma Services was founded over 15 years ago by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision inmind, these physicians brought life to BioPharma withworld-class leaders, innovative scientific expertise and state-of-the-art facilities. Leading Providers of Bioanalysis and Bioanalytical Services 2021 Getting a new drug onto the market is a process that can take many years. BioPharma’s seasoned team of physicians, scientists and clinicians are dedicated to helping clients ensure drugs that are being developed are safe and effective, and clients can take advantage of its robust database of healthy volunteers and special populations including recreational drug users and post-menopausal/ surgically sterile females. The company has built a full suite of clinical trial solutions from Phase I to BE/BA services to assist its clients’ clinical drug development programmes. With two cutting-edge clinical facilities which have a total combined 300-bed capacity in Toronto, Ontario and St. Louis, Missouri, BioPharma has conducted approximately 2,500 bioequivalence and Phase I clinical trials and counting. It has experience conducting Phase I trials across a wide range of therapeutic areas, including neurology, cardiology, immunotherapies and infectious diseases. BioPharma’s labs are led by experts with over 20 years of expertise, its bioanalytical lab in Toronto equipped with the latest LC/MC/MS platforms [JL2] to meet the demand for detecting increasingly lower amounts of drugs in biological samples. The company also develops novel assays and extraction methods that deliver consistent, accurate results on expedited turnaround times. The company knows how hard it can be for businesses to select the right CRO for their drug development programme. That’s why it works so hard to ensure that it is with the client every step of the way, right from the first point of contact. BioPharma provides a full-service CRO from study design inception to clinical trial execution, with data reporting and tabulation to the final clinical study report. Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of its people – The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness. It is with the same culture and brand of excellence that BioPharma welcomes its clients. To experience the team community that has propelled it into a global leader in medical research, to be a client-focused partner, where people and patients matter. Company CEO, Renzo DiCarlo said, “I have been humbled by the spirit and dedication of our people. It empowers me to see them execute high-quality medical research in order to bring much- needed pharmaceutical products to the market. BioPharma Services is an exciting place to work – full of passion, integrity and commitment. I look forward to the next ten years of innovation and drive.” In this highly regulated industry that is governed by the international quality standard of GCP and GLP, it is paramount that the company’s process, quality and governance never falters. Adhering to the principles set forth by the ICH, BioPharma’s unwavering commitment to quality and safety standards is supported by its history of regulatory inspections which spans across markets. They include routine regulatory inspections by the US FDA (Food and Drug Association), UK MHRA (Medicines and Healthcare products Regulatory Agency), ANSM (French National Agency for Medicines and Health Products Safety), DKMA (Danish Medicines Agency), ANVISA (Brazilian Sanitary Surveillance Agency), Health Canada, World Health Organisation and a GLP certification by the SCC (Standards Council of Canada). Ultimately, BioPharma’s number one objective is to exceed its clients expectations through teamwork and its proactive “can do” attitude, while being agile enough to pivot and make adjustments when needed. Its dedicated project managers work closely with the client to ensure all aspects of their trial are well- managed with fully transparent communication, and inhouse experts including PK, data management and medical writing deliver the results the client needs, when they need them. Contact: Carol Estwick Website: www.biopharmaservices.com