With the increasing demand for newer and safer pharmaceutical products, Contract Research Organizations, (CROs), have rapidly become a force in drug development and clinical trial recruitments and into the post-marketing safety arena. To highlight one such company, PharSafer®, has quietly and swiftly innovated and developed robust systems as its primary route to provide the best clinical research for drug development Companies large and small.
The company offers a breadth of vigilance operations (The A – Z for Pharmacovigilance) for its clients, ranging from Pharmacovigilance to Cosmetovigilance, Materiovigilance, Advanced Therapy/Biologics vigilance, Vaccine safety, Nutrivigilance, and Veterinary Pharmacovigilance.
In addition to assisting the clients with audit preparedness through its ‘White Gloves Audit Group’, PharSafer® offers global medical services and industry training courses for fellow industry and regulatory professionals from introductory through to intermediate and advanced levels on wide-ranging topics.
We at Insights Care got an opportunity to interview PharSafer®’s, Director, CEO, and Owner, Dr Graeme Ladds. He shared some valuable facts about the company showcasing the fundamentals of being one of the prominent companies in the CRO healthcare sector.
Below are the highlights:
Please brief our audience about your company, its USPs, and how it is positioned as a reliable name in the CRO sector?
Founded in 2003 by Dr Graeme Ladds, PharSafer® is an International Contract Research Organisation (CRO) specializing in Global Clinical and Post Marketing Drug Safety and Medical Services, with a wealth of varied experience in Pharmacovigilance, Medical Affairs, and Medical Information – and the different, numerous and extensive legal safety or medical obligations for license holders and clinical sponsors to comply with.
Through our five core business sectors- Pharmacovigilance, Training, Audits, Medical Affairs, and Informatics, our clients always know who they can speak to for any request. They do not just get a provider – they get a partner offering advice and expertise to develop their drug safety systems cost-effectively and compliantly.
Please shed some light on your offerings and how they impact the CRO industry and your clients. How your company provides research services to various organizations?
In our people and our processes, we have a first-class business and deliver a service to match. We ensure all operations and communications are conducted with full transparency with our clients to ensure a synergized approach and deliver on our promise towards providing enhanced global patient safety, all while operating our Quality Management System to ensure both compliance and consistency.
Through our journey, over time, we have acquired additional expertise in advising and informing our wide-ranging client base of the best possible solutions within an extremely complex, ever-expanding, and a global industry where regulations continuously change.
Our global expertise comes from our highly skilled team of Physicians, PhDs, MSc scientists, and Pharmacists with many years of experience in pharmacovigilance and medical services. We apply this experience in collaboration with other skilled members of our PharSafer® family – to not only deliver a first-class service for our clients but to continually research, develop and implement innovative processes, procedures and products for the benefit and advancement of the wider industry.
We achieve this, working together with our sister company – SaPhar Training® – PharSafer® trains client Companies, runs bespoke training courses for large and small Pharma, ensures the highest training standards for PharSafer® personnel, and continuously seeks new and innovative ways to provide added value for our clients, going above and beyond expectations and optimizing our many detailed processes and procedures involved with clinical and post-marketing drug safety and medical affairs.
What are the core values upon which your organization is built? What is the vision and mission of your organization?
Overall, our mission is to keep each and every one of our clients compliant as the international environment evolves leading them through the global maze that is drug safety regulation, with exceptional quality of service forever at the forefront of our thoughts.
To support this, we have core values that govern how we operate and shape who we are as the client’s pharmacovigilance partner. In 2019, we performed a values audit to ensure our values are reflected by our people by completing a companywide survey of all employees and identified the prioritization of patient safety above all else as our core value and are proud to say that this value drives each and every decision we make, from our most senior of staff to the most junior, in all of our locations.
We imbue in all of our staff honesty, integrity and pride in performance, so that we evolve to get better at what we do.
Being an experienced leader, share your opinion on how modern technologies have impacted the CRO sector. How has your company incorporated such technologies into its daily operations?
Having worked within the industry for over 30 years internationally and with a team of senior professionals with over 150+ years of experience in pharmacovigilance, we have witnessed the industry evolve significantly over time with greater and more stringent requirements as well as greater complexity. We believe the industry is again rapidly approaching the need for innovation through automation to offset the increasing resource demands and costs.
PharSafer® has previously been involved in developing new, validated safety and medical information databases and has many new ideas to enhance safety practices to improve patient safety, compliance and speed of processing reports.
With demand for adverse event case processing increasing year-on-year, the cost of recruitment and training on the rise, human errors found within the processed safety data, lack of timely and consistent follow-up, and late case submissions all continuing to be reported as regulatory inspection findings, the need for improved safety data capture and reporting of adverse reactions, for both clinical and post-marketing, has never been greater.
It is with this belief that we have developed R.A.P.T.A. R® – The Rapid, Automated, Processing, and Tracking of Adverse Reactions for both clinical and post-marketing drug/cosmetic/device/vaccine safety – with the vision to advance the industry on a global scale.
What would be your advice to budding entrepreneurs who aspire to venture into the CRO space?
For those wishing to do what has been achieved with PharSafer®, I would suggest that planning, planning, and more planning to ensure there is a clear and achievable pathway forward for developing into a CRO is plain for all to see. First, start with Quality. Build the Company foundation on Quality which may slow down growth initially but will place the Company on the right track moving forward. Next expertise, soak knowledge up like a sponge to use for clients. Third be flexible, no two clients are the same and must be treated as individuals you fit them, they do not fit you and your processes – having said that advise them if you know a better way.
Finally, forget the clock. To achieve, maintain and grow the organization requires commitment and passion. This means a nine to five approach for clients, and the business is ignored to gain the standards required by the Regulatory Inspectors, clients, and staff as they develop their careers with us.
How do you envision scaling your organization’s operations and offerings in 2022 and beyond?
In order to increase our presence and scale, this year and beyond requires investment in the people that work for us and ensure they have comprehensive training programs to develop their skills, thereby strengthening the expertise in the Company, for the Company and enabling more staff to perform varied duties for our customers.
In addition, we are innovators and lead the way. We invent, develop and introduce global systems that enhance safety and medical systems, automating labor-intensive tasks fraught with quality issues and advancing overall pharmacovigilance and medical approaches to patient safety.
In relation to creating innovative solutions, the PharSafer® senior management is supported by all of the staff in developing the platform and designs for the PharSafer® Informatics department. We are global leaders in our field, and by enabling unique IT solutions, we ensure the benefit for all of our clients. This means that we won’t be stopping at only enhancing case data capture and processing with R.A.P.T.A. R®., there is much more in the pipeline.
Strategic and Critical Leadership
With a first degree in Biochemistry and Pharmacology and a PhD focusing on drug metabolism and Pharmacokinetics Graeme has worked in the areas of Drug Safety and Medical services for over 30 years.
Graeme has been working as Head of Global Pharmacovigilance for a multi-national innovator Company, and EU QP PV for many of the top ten Pharma Companies, and small Pharma and has been CEO for the last 19 years for PharSafer®.
Graeme is also a member of the DIA; TOPRA; RQA, and the Institute of Directors and PIPA and has helped small start-up Companies (Biotech; Medical Devices; Biologics; Generics; Herbal; OTC) in their planning, growth and has been involved in Company and product acquisitions, due diligence activities for product in-licensing and marketing and development strategies with partner and distributor Companies.
Graeme has been involved in many drug development programs, taking products from the bench to market in a wide range of therapeutic areas.
Graeme also has an additional role as Research & Development Director for products to be developed for global launches.
His 31-year journey in drug safety, where there was little structure to be trained in pharmacovigilance or availability for finding out the global regulations, fueled his desire to ensure there would be an extensive training program for all the PharSafer® people to promote and simplify their drug safety careers. This has resulted in many staff now has remained with the Company for over ten years, providing Company stability and in-depth expertise. Additionally, to aid all drug safety professionals in their careers the PharSafer® sister Company SaPhar has performed training all over the world with varied bespoke and formatted training courses for all levels of experience since 2003.