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Pivotal: An Inventive Approach of Designing and Performing Clinical Trials

Ibrahim Farr of Pivotal
Ibrahim Farr of Pivotal

Contract research organizations are emerging as important partners for pharmaceutical and biotechnology companies to conduct clinical research. But with several CROs mushrooming in the market, the pharmaceutical and biotechnology companies are at times confused as to which suits them the best.

For pharmaceutical and biotechnology companies, CROs have become exceptionally valuable partners, specifically for the progress of new drugs. As there are several CRO’s vying in the market, the most prevalent issues arise:

What are the most trending updates within the contract research niche for Pharmaceutical and Biotechnology to be aware of? Which will be the most suited option to select among so many? And according to their priorities, what are the cursors to be looked at?

In this edition by Insights Success, “10 Most Reliable CRO’s to Watch in 2021” we will acme the excellence of these CRO’s that make them the top ten most reliable CROs for you to be affiliated with.

In our aspired search of the foremost CRO’s, we came across Pivotal S.L.U. It is a contract research organization that offers a variety of contracting models, from a single source to full service in the chain of drug development activities, from start-up to completion of the corresponding final study report.

Pivotal’s scientific team provides risk-management strategies for their client’s products to make it the most brilliant choice in the market. In the following interview, Dr. Ibrahim Farr, Chairman and CEO of Pivotal S. L.U. uncovers about the company’s journey about how it has developed into one of the premier CROs and his opinions about the market that their company serves.

Please brief our audience about your company, its mission, and the key aspects of its stronghold within the contract research niche.

Pivotal was founded back in November 2001 by Dr. Ibrahim Farr– with the ambition to become a full-service and therapeutically focused CRO. It has been permanently operating for almost 20 years, 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 our clients and not merely as ‘doers’. It has been providing tactical as well strategic advice in the Clinical Trials landscape.

Today, it is headquartered in Madrid and is legally incorporated. It has provided services in >22 countries across Europe. We count on Pivotal’s staff proper in most of these countries.

Our goal was then and still is to provide our clients with high-quality services across the value chain of drug development activities, from start-up to completion of the corresponding final study report.

Although Pivotal is an EU-focused CRO we do have solid established and well tried and tested partners in the US and Asia Pac.

We are a full-service organization covering all tasks needed in drug development, with a strong medical and scientific focus and across all therapeutic areas. Major services provided within our services portfolio are:

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 patient journey services.

We have been awarded to face and succeed in all projects. Pivotal counts with an energetic, long-experienced, client-oriented and committed personnel, always seamlessly pushing forward to drive our clients’ trials and studies to the right place.

Pivotal is proud to offer 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.

Lastly, we want to stress that we are committed to new technologies and challenges and are on the way to promptly make a shift to – or at least also offer – the possibility of designing, conducting, and managing that new kind of virtual clinical trials with all their new specific requirements and demands. We will not lag.

Tell us more about the offerings which make your company stand out from the competition?

Below are, in short, major reasons why we think Pivotal may be a preferred option for several companies, which are looking for a CRO to partner with when planning to set up and conduct a clinical study:

– Client-oriented approach: Our senior management is approachable and directly involved in the clinical studies. Our operational team is energetic, client-oriented, and deeply knowledgeable

– Full-service solution

– Therapeutic focus across many areas

– Cost-effective solution

– Scientific expertise with the internal medical division staffed our medics, specialists in several areas like – oncology, hematology, clinical immunology, cardiology, internal medicine, CNS, and more. And will be the backbone of the trial by bringing in-depth therapeutic expertise and strategic advice

– Geographical reach across Europe with solid partners in the US

– One-team attitude, integrity, and commitment

What is your opinion on the impact of the current pandemic on the global CRO vertical, and what challenges did your company face during the initial phase of the pandemic?

Challenges have been felt and encountered by all CROs while providing clinical research and services to those Pharmas and Biotechs like Pivotal did throughout the pandemic.

Nevertheless, we consider the pandemic a good opportunity to streamline processes as well as bring to life a new methodology for drug development.

New technologies on one hand, and the COVID-19 pandemic on the other, are demanding us to re-think the old in-house procedures. For example, no paper anymore and imposing the learning of how to manage trials involving the use of those new technologies, and which walk close together with the handling of clinical trials from a new ‘virtual’ or ‘decentralized’ perspective.

And these are likely the most defiant challenges long track-record CROs like Pivotal will have to deal with rapidly. At Pivotal, we understand all these demands and are committed to new thinking paradigms and technologies.

The COVID-19 pandemic has forced Pivotal to adopt new working ‘remote’ scenarios, and although many of our studies have been impacted by COVID-19 and none have been particularly delayed or cancelled because of this.

With continuous development in technologies such as AI and big data, what is your prediction about the future of the CRO vertical?

Today, we have done enough research on the same and have worked towards removing paper from most of our procedures. We have even developed a proper internal bred cloud-based trial tracking system called ‘Danah’, which includes solutions to create robust and reliable tracking systems and eTMFs.

All in all, we are learning fast and have the wish and commitment to walk with the times and offer our clients modern accurate solutions for their projects. We are ready to rapidly assist our clients to shift to this new environment by leveraging all newly available tools.

As an established leader, what would be your advice to the budding entrepreneurs and enthusiasts aspiring to venture into the contract research niche?

The first piece of advice is that an entrepreneur venturing into this industry should be scientifically and quality minded. Secondly, he/she should focus on delivering high-quality work to help bring new medications to the clinic, to address the unmet medical needs of many patients and support the advancement of Medicine.

How do you envision scaling your company’s operations and offerings in 2021?

Much of the story discussed in previous sections has to do with the expected coming of a new way of planning and conducting clinical trials. Certainly, CROs will have to adopt these new requirements and learn how to play in the new virtual scenario but ancient typical problems of clinical trials will still be there.

And we believe that one of the most important hurdles in all R&D work has always been and will be patient recruitment. Strategies to optimize enrollment shall always be considered as these may enormously help to warrant that target figures to provide robust and sound scientific conclusions are met and to help control the budget of the project when enrollment issues are noticed. too late. This will help in the prevention of incurring additional costs.

At Pivotal, we are quite conscious of how lack of adequate enrollment may impact the trials of our clients and hence Pivotal has 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.

Therefore, with the aim to improve patient outcomes always in mind, we have developed and embraced patient-centric thinking. And our patient-centered services leverage the patient´s perspective to enhance awareness, recruitment, and retention. C-Lys is our cloud-based patient management platform, fully customizable to your studies, which may provide a range of automation and survey solutions to efficiently manage patient recruitment.

Exhibiting Excellence

Pivotal has adhered to the Alliance for Children´s Vaccination as well as other NGOs in the area. Pivotal collaborate along with Gavi, an international organization and Global Vaccine Alliance, in the fight against children’s mortality in the world’s poorest countries. Pivotal has been selected as one of the few firms that attracted recognition from the Pharma IQ network as a ‘RISING STAR’.

This survey was performed independently by Pharma IQ among their international community members who were asked to nominate CROs for 2018, which they recognized as the leading and the best in the pharmaceutical and biologics industry based on their own experiences.

The research base was made up of international participants from mainly big pharma or biotech, SME pharma and consultants, government bodies, medical device manufacturers and public hospitals.

The above is just a sample of the awards and recognitions received, which are very much related to our client’s continued confidence and trust in Pivotal as their valued partner in clinical research and the quality of services Pivotal provides across a broad spectrum of clinical trials and therapeutic areas.

About Dr. Ibrahim Farr

Dr. Farr is MD by training and specialist in psychiatry and pharmaceutical medicine. And has brought Pivotal thirty years of experience in drug development. He has worked in companies like – Marion Merrell Dow, Cyanamid/Wyeth, and Rhone-Poulenc Rorer/Aventis.

Dr. Farr has devoted his life to clinical research and drug development from both the Pharma and the CRO side.

It is the result of spending years in managing clinical research for the Pharma sector, and thanks to his scientifically driven mind that he realized how important it was to count on solid strategic medical advice and support as the backbone of all clinical trials.

Then he jumped out of Pharma and transited to the CRO side as he founded his own company ‘Pivotal’, with a purpose in mind, to not merely activate and conduct trials, but also ‘think the trials’ for and with the clients themselves while walking with them hand in hand all the way down.




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