Pharmaceutical companies have been increasingly using outsourcing to be to be more efficient and effective in drug development, help reduce time-to-market and boost the ongoing commercial success of their products. This shift is accelerating M&A across many segments of outsourced pharmaceutical services. Across the pharmaceutical value chain, outsourced services are gaining traction, from drug discovery, contract research and contract manufacturing to commercialization services, safety and risk management and pharmaceutical IT.
CROs generally employ an expertise-driven, project-based consulting model that requires strategy and capability around managing complex trials. Most importantly, while some large service providers exist in this segment, significant consolidation opportunities exist. In comparison, the preclinical CRO market is more mature and consolidated. Over the years, many large pharmaceutical manufacturers have moved from working with a set of preferred providers to forming strategic partnerships with only one or two large CROs.
Nevertheless, other pharma and, preferably biotechnological, companies do still prefer to work with a set of qualified mid-size CROs in order to provide them with more personalized focused specialized services.
With the objective of becoming a reliable full-service CRO, Pivotal was born back in 2001 on the principle that strategic scientific and medical advice and support should be the backbone of all clinical trials with proper and sufficient resources to cover not only the execution of all essential aspects and stages of clinical trials from setup to execution to termination, including clinical monitoring and project management.
Under the leadership of Dr Ibrahim Farr, Chairman and CEO, Pivotal also oversees other complementary activities such as medical monitoring and writing support, or pharmacovigilance and data-management and biostatistical services, i.e., almost all that it takes to complete a clinical trial, while just leaving some very specialized tasks (e.g., drug depot services or lab. analytics) in the hands of very specialized vendors independent from the company.
The Profound Legacy
Now, almost 21 years from its foundation, Pivotal’s team is proud of being involved in the activation, conduction, and the execution of discrete full activities of nearly 500 different clinical research projects in quite distinct therapeutic areas and phases and with many diverse investigational compounds, devices and products.
With some more detail, Pivotal has been engaged, up to date, in a total of 361 clinical trials – from phase 1 to phase 4- that involved the management of almost 6,000 investigational sites and >40,000 patients and in close to 115 non-interventional studies (NIS) which involved, in turn, the handling of >9,000 sites and >62,000 patients. Or in “big numbers”: an accumulated experience resulting from working with >15,000 sites and >100,000 patients – a heavy backpack to support its expertise and knowledge.
Pivotal’s team genuinely believe this all has only been possible because of their proven experience in and deep knowledge of the clinical research landscape and because of the high quality with which Pivotal´s associates face and manage all clinical projects that have been entrusted with – all of these aspects a trademark of Pivotal and which have warranted an essential number of clients repeating business with us (almost 75% of repeat business), and others turning to Pivotal to assume the rescue of their on-going trials when “not flowing” as planned (some 32 clinical trials to date).
Yet, and aside from all those more general and technical features defining Pivotal, the team believes that its most essential strengths come not only from themselves but also from its internal culture and a unique way of approaching their clients and their concerns, always from a personal perspective and commitment to deliver high-quality results.
The Continuum of Success
Over the years, Pivotal has succeeded in attracting – and retaining- exceptional associates, all committed to and passionate about clinical research and delivering medical solutions much closer to patients. Such “exceptionality” can be found at all operational levels, and its staff – particularly its senior management teams- is absolutely approachable and directly – and personally- involved in all projects that the company collaborates with.
Pivotal and its associates are pretty aware of how costly and crucial every single project might be for the clients. They feel unable to get into any clinical study – ample or “tiny”- without putting the company’s experience and knowledge into them.
When working with Pivotal, clients do not simply work with “individuals” but with a robust team driven by a “oneteam” attitude, commitment, and integrity. Pivotal tries to keep its customers in the center of its work, listen to their inputs, and put itself in their shoes to better comprehend their needs to become an extension of their teams.
Last, it is important to mention that apart with its clients, Pivotal aims to stay connected with the “ecosystem” – namely, the whole clinical and innovation communities- to warrant in-time access to breakthrough science, best sites, talent, and technology—delivering daily to its clients, and making sure every deliverable, document, slide, or message is clear, adds value and, eventually, reduces time to market.
This all is what, the team believes, has made Pivotal a favorite partner for a high number of Biotech and Pharma companies.
Adapting to the post-COVID-19 Clinical Trials Scenario It was undoubtedly unthinkable back in 2019 that a “catastrophe” like what the COVID-19 pandemic has represented could simply happen and, much less predict all the effects it brought alongside – at a global level and, obviously, at any smaller single compartment of human lives, including the clinical research ecosystem. Analyzing how COVID-19 has impacted the clinical trials – and may impact in the future- is not a straightforward question but rather a polyhedric complex problem requiring simultaneous looks from quite different but complementary angles.
Firstly, it has affected all companies developing new medical solutions for patients, including Biotech and Pharma and other supporting-services companies like clinical CROs. Then, undoubtedly, it has impacted the organization of investigators at investigational sites who had had to adapt, from one day to the next one, to a different way to handle and manage their clinical research activities and their patients – with patients not able to attend their visits at the sites.
And last, likely the most critical link of the chain, it has had an impact on thousands of patients being treated in the context of clinical trials, frightened that the hopes they put in every new treatment they were helping to develop for themselves and for others may simply fly away. However, despite the potentially terrible scenario that COVID-19 may have resulted in, all actors involved in clinical research have found a way to move forward and overcome all hurdles encountered.
Indeed, the COVID-19 pandemic and all lessons learned will condition the clinical trials arena in the future and how all actors involved play their respective roles. And potential new clinical research scenarios and rules will need to be considered, yet still maintaining patients at the very core, warranting their rights, hopes and illusions and having them reassured at every moment – may other pandemic burst out (or any other similar event) that they, patients, will be treated as needed and deserved.
Among the lessons taken from the “COVID-19 experience, Pivotal has learned that there are alternatives to the classical face-to-face visits to sites and that data can still be collected and verified remotely as much as possible. But also, others by simply using online technologies that allow patients to transmit outcomes, as per the corresponding protocol. Or in other words, the COVID-19 pandemic has probably opened up the door to that new type of decentralized clinical trials (DCTs). Advantages, disadvantages and challenges of DCTs vs. centralized trials will require, on the other hand, deep discussion in another article and this is beyond the topics that pretend to be now covered.
Pivotal also experienced that during this COVID-19 period, the study treatment – commonly administered at each investigational site- can be efficiently delivered to patients by post or courier to the safety of their homes for self-administration.
And that even for more complex administration routes requiring, for instance, injections, specialized staff may visit patients at their places for dosing – and, why not, to collect samples as needed. Nevertheless, and despite the alternatives just pointed out and applied by Pivotal, there will surely be many procedures, trial activities and measures or trial compounds – e.g., particularly unstable- that will not allow an easy shift to this potential new model of making clinical research home-friendly.
Be as it may, the “take-home” message from the COVID-19 outbreak is that alternative ways of doing clinical research are possible and that “rethinking” clinical trial designs and operational approaches are much more than recommended. All parties – from sponsors to investigators and sites to patients and regulators- must change their mindsets and look at these alternatives with interest since they may also help to reduce the overall costs of clinical investigations. And Pivotal and other clinical CROs, on their side, will have to adapt their operational procedures to this new clinical research (remote) environment – surely, a long way to go ahead, but much motivating.
Innovation and new technologies will be the basis of this potential transformation, which is already in Pivotal’s DNA. Thus, the company meets the first “inclusion criterion” for this new environment and paradigm shift.
And for the future, the company considers, if not entirely shifting to DCT-like approaches, at least to start walking that new pathway parallel to the classical one. Pivotal definitely wants to play the new game but always remains true to its client-oriented and patient-centric attitude, its commitment, and strong belief in science and quality as the basis to build on medical discoveries and advances.
Embracing the Future Roadmap
The CRO market is constantly moving, and on the basis thereof, “M&A” processes rely on. And as a consequence of this, new giant actors emerge every year while smaller CROs suffer, if not literally close the business. Niche specialization or shifting to new target sponsors – e.g., biotech- may help them to survive and thrive, though. These are certainly the market rules but are a trend that may deprive the smaller innovators Biotech of partnering with the right-size yet experienced CROs if no other actors can be found out there. Not much to do to stop the market’s hunger, but just sending a message to smaller innovators and sharing the thought that rightsizing is still a valid principle for sponsors to consider when selecting their partner CRO – hence, mid-size CROs such as Pivotal will surely be much more agile and will put their clients’ projects among those much more important for the client. Mid-size and smaller focused CROs are likely different from merged giants in that they may be just one more team member of their clients and work incredibly close to the proper clients´ internal teams. And at least, this is what the company has been doing and pretending at Pivotal and what has been the basis for its success story to date.
The future starts today, actually, and for 2022 Pivotal intends to keep growing while remaining faithful to the “organic growth” policy it has been following since inception – rather than basing its expansion solely on “M&A” operations-. Therefore, the company plans to offer something else to entice old and new clients.
COVID-19 outbreak has pointed out the new pathway to follow -DCTs, digitalization, technology- and, as already mentioned, this is a maneuver in which the company has already been investing to get there. But in the short term, Pivotal plans to work towards giving an impulse to the science behind clinical research.
With this objective in mind, the company has onboarded new talent forged in a research-making environment with a proven capacity for planning and conducting experiments and, importantly, for analyzing, interpreting, and publishing results.
Pivotal’s ultimate idea is to provide such strategic scientific analysis and advice to its clients in every new project it is awarded, in real-time, so that rapid but robust decisions on how to progress forward can be made, avoiding the compromising of a total budget in a project that may have lost sense or which may benefit from re-focusing.
An independent Look at Pivotal
Pivotal is proud of being the foundation it is today, and its team believes in “we-are-Pivotal”; hence it runs the risk of acting subjectively when giving marks to the company. External independent opinions may help, though. These words of wisdom showcase the status quo of Pivotal—being one of the innovative CROs in the healthcare industry. Detailed quotes are depicted in our website at www.pivotalcr.comand at our patient journey arm division at www.pivotalpatientjourney.com and below is an example of these quotes:
“Pivotal continues to be my CRO of choice. They complement our existing team by providing functional area expertise that we do not currently possess. Their personnel are highly engaged, experienced, and proficient in what they do. Pivotal’ s leadership team is experienced and more importantly, incredibly engaged throughout the entire study.
These are some of the reasons Pivotal continues to be a trusted partner for us.”
- Chief Operating Officer, at a US-based Medical Device Co
“I have worked with Pivotal on two studies and have been particularly impressed with the care they give studies, their personal attention to the needs of sponsors, and their dedication to getting things right. Pivotal is a closely-knit group. There is no bureaucracy, simply the dedication to serving the needs of their biotech clients. They are the closest thing I can find to having my company personnel on the ground in Spain and Europe.”
- Chief Medical Officer, at a US-based Biotech Co
“The team at Pivotal operates as a seamless extension of our internal team, building trust with our European clinical trial sites and our confidence in our ability to execute high-quality clinical trials. The Pivotal management team acts as a true partner, equally focused on our objectives to develop innovative therapeutic treatments for patients with serious unmet medical needs.”
- Group Vice President, Development Sciences Operations at a Mid-Size US Pharma Co
“As an independent investigator and head of a Cooperative Group, I have been working with Pivotal since 2014 on six projects in GU tumors and what I have encountered is a dedicated team to clinical research, very much attentive to the complex needs of independent investigators, responsiveness and quality-minded throughout.
The team gets it right the first time in all the services, including regulatory and clinical operations, medical and safety monitoring, data management, and biostats. Pivotal is my favorite CROs to work with, and I have no hesitation in recommending it for any new trials in Oncology and beyond in Europe.”
- Senior Researcher PSMAR/IMIM Hospital del Mar, Barcelona, Spain, and Associate Professor of Medicine Harvard Medical School
“I have worked with Pivotal on international clinical trials both of an ICU therapeutic and a cancer screening device/diagnostic. I cannot think of a better partner. A cost-effective collaborator with deep functional expertise, particularly in data management, biostatistics, medical monitoring, pharmacovigilance, and project management, but even more importantly, a company with a culture of problem-solving and shared responsibility.
Working with Pivotal is never “us” and “them” it is one shared mission with a group of professionals who simply do whatever it takes to accomplish the goal. This starts at the top, with the credible, expert, and ever-present leadership of the CEO, himself a former senior Pharma drug developer, and filters through every layer of the organization.”
- CEO, at a US-based Biotech Co.
“The patient recruitment process has been awe-inspiring, and I have learned a lot through your company and your CL ys patient platform. You are making the world of research a better place with your company and your ways.”
- Ophthalmologist and PI and Med. Monitor lead in FDA-monitored clinical trials.
“And all of the above seems to be supported by the fact that Pivotal was selected as one of the few firms that attracted recognition from the Pharma IQ network as a RISING STAR.”
The research base comprised international participants from mainly big Pharma or Biotechs, SMEs pharma and consultants, government bodies, medical device manufacturers and public hospitals. We have kept doing as good as then, so we are confident we will surely be perceived now as we then were. Clients have the last word, but business coming in aligns with this feeling