A Contract Research Organization that weaves together the scientific insight, the technology and the resources to help customers address both current and future needs: Pivotal

In recent times, the range of activities that are contracted out to third-party companies by major pharma corporations is increasing rapidly. This has led to a lot of changes in the relationship between the two parties involved in the deal. As an attempt to lower fixed costs and reduce the skill gaps, drugmakers are now actively reaching out to contract research organizations (CRO). The basic functions of a CRO are managing the contractor company’s clinical trials and performing tasks related to bringing a device or drug to the market. CROs generally contract with companies working in biotechnology, medical device manufacturers, or pharmaceuticals, but their client base extends to universities, government institutions, and foundations.

Globally there are various CROs providing excellent services, but Pivotal stands out from the rest. Pivotal was founded some 20 years ago on the principle that strategic medical advice and support should be the backbone of all clinical trials. It was recognized since then as an EU-CRO with a solid internal medical franchise that could act as “co-thinkers” for its clients (and not merely as “doers”), providing tactical as well strategic advice in the Clinical Trials landscape. With this benchmark always present, Pivotal has progressed and has grown to become what it is nowadays and is considered by most of the clients as a trusted adviser and counselor and a doer for delivering maximum value in their drug development programs.

The main goal of Pivotal was, then, and still is to provide its clients with high-quality services across the entire spectrum and value chain of drug development activities, from start-up to completion of the corresponding final study report. However, this transit is normally a long-way that requires the involvement and collaboration of diverse clinical trial professionals. To cover such complicated demand, Pivotal has put together an experienced and committed team of professionals and is currently able to cover all the critical aspects behind the initiation and conduction of a clinical trial.

In conversation with Dr. Ibrahim Farr, Chairman and CEO of Pivotal

Q. Explain your services in brief

In summary, Pivotal’s main features since inception are:

• Strong medical and scientific drive and focus
• Therapeutically-driven CRO across all our divisions
• Full-service CRO, including the below services
• EU-focus with solid established and tried and tested partners in the US and Asia Pac

In this sense, Pivotal counts with a complete portfolio of services that include the ones listed below, and that can be offered in a variety of outsourcing models, from single source to full-service, but always ensuring flexibility to our clients. The main services Pivotal can cover and provide include the following:

• Regulatory Affairs and Study Start-Up
• Clinical Trial Monitoring and Sites / Projects Management
• Data Management and Biostatistics
• Medical Monitoring
• PVG Services
• Quality Assurance and Auditing
• Biotech Consultancy

And on a separate note, it should be mentioned as well that to face and succeed in all projects we are awarded, Pivotal counts with an energetic, long-experienced, client-oriented, and committed personnel (mostly full-time employees proper) always seamlessly pushing forward to drive our clients’ trials and studies to the right place. Pivotal is proud to offer to all its clients highly customized teams that bring a combination of broad industry knowledge and operational excellence that allow us, in turn, to offer our clients fresh perspectives and breakthrough business insights.

Also, and in addition to this, it should be noted that Pivotal’s Senior Management provides strong scientific development expertise, with an important global background acquired in their previous affiliations to Pharma companies. Nevertheless, our senior management is absolutely approachable to our clients and is always directly involved in the clinical studies to help achieve more predictable deliverables.

What are the challenges addressed by your solution in clinical trials?

Although core-part of most of the clinical trials and studies tend to stick to, more or less, standard demands and requirements, many of them do actually require special extra efforts and putting in place alternative (and imaginative) solutions to certain project-related issues, which may arise from the trial design itself or because of non-expected exceptional situations – like that imposed by the COVID-19 outbreak as an example. At Pivotal, we have had to deal with this type of issue – no matter what they imply- have learned from the experience and feel ready to face more projects demanding to go a bit further than in “conventional” trials.

There are many of these challenges and include from the selection of site and investigators; concerns related to a target population that becomes hard-to-find or other (minor but complicated) particularities that may include the management of patients’ lodging (when needed), the delivery of medication to patients when at-home, and even the completion of study procedures or other activities like the coordination of the payment of patient stipends or reimbursements.

Apart from oncology, what are the other major divisions that can make use of your services?

Oncology/Hemato-Oncology is just one of the therapeutic areas in which Pivotal is positioned – likely the most important and in which we do have much more experience and a long story to tell- but yet this is not for sure the only clinical research segment that we can cover. Thus, and when talking about therapeutic areas or types of investigational products we work with, it is true that oncology projects and drugs do lead the list, but they are not alone. In fact, at Pivotal, we are good and have much experience in the so-called rare diseases and orphan-drugs and can provide much support to developers targeting such conditions and products.

Be as it may, at Pivotal, we are used to also working in other therapeutic areas that include the cardio- and cerebrovascular conditions; infectious diseases and vaccination (including COVID-19); immune-based diseases; endocrinology and metabolism; those related to malfunctioning of the CNS and many others.

And importantly, and aside from what relates to therapeutic areas, it should be highlighted again that Pivotal is a full-service clinical CRO able to provide our clients with a complete solution for their clinical research projects – including activities like DM; BS or safety evaluations. And if something is not available in-house, we can provide it via 3rd-parties – our experience strongly supports this point.

Do you have any new services ready to be launched?

We believe that one of the most important hurdles in all R&D work – which may make a difference, demand spending additional time and money, and which may be worth it to analyze before launching any project-  is, undoubtedly, patient recruitment. Strategies to optimize enrollment shall always be considered. These may enormously help to warrant that target figures to provide robust and sound scientific conclusions are met and help control the project’s budget, preventing from incurring additional costs when protracted enrollment issues are noticed.

At Pivotal, we are very much conscious of this and have recently acquired and rebranded as “Pivotal Patient Journey”, an independent EU-based company focused on accelerating patients and healthy volunteers’ recruitment within Europe and the US. And this support is already available to our clients.

We have already mentioned that innovation is part of Pivotal’s DNA, and therefore we are highly committed to implementing technology-enabled measures to improve tracking and monitoring of our trials in real-time and in a centralized mode. In this sense, Pivotal has just completed and implemented a proper, internally-bred, cloud web-based tracking system – Danah- that has been rolled out and which will provide trial-related data and metrics for our staff as well as for our clients. Moreover, we have recently launched our “e-Trial Master File (eTMF)” - functionality of Danah which is now also operative.

What does the future hold for your company and its customers? Are exciting things on the way?

Hard to say what the future will hold for Pivotal and our clients and partners, but it will surely bring new challenging and stimulating opportunities to collaborate in the development of new cures, treatments, and diagnostic tools which will, in the end, help patients to have much better and happier lives. There can’t be a better reward.

Meet the leader behind the success of Pivotal

Dr. Ibrahim Farr is the Chairman and CEO of Pivotal. Dr. Farr is MD by training and specialist in psychiatry- and brings to Pivotal some thirty years of experience in drug development, completed in companies such as Marion Merrell Dow, Cyanamid/Wyeth and Rhone-Poulenc Rorer/Aventis.

Dr. Farr has almost devoted a life to clinical research and drug development from both, the Pharma and the CRO side. And it was after some years of managing clinical research for and within the Pharma sector, and thanks to having a scientifically-driven mind, that he realized how important it was counting with a solid strategic medical advice and support as the backbone of all clinical trials. Then he jumped out of the Pharma and transited to the CRO side by founding his own company – Pivotal- always with that purpose in mind; namely, not merely activating and conducting trials, but also “thinking the trials” for and with the clients themselves while walking with them, hand in hand, all down the way.

We have the key responsibility to build-up a better clinical research and development world for the patients and society at large and our people and clients across all therapeutic areas with unmet medical needs”