Overview

Our story

Pivotal was born in 2001 surrounded by an environment of high scientific tenure and drive, on the principle that strategic scientific-medical advice and support should be the backbone of all clinical trials. Our founder, Dr. Ibrahim Farr, launched Pivotal with the aim of sharing and implementing scientific strategies and best project practices to make clinical trials more efficient while maximizing the value for our clients’ drug development programs. Today, we are the trusted advisor and counselor for many companies delivering maximum value in their drug development programs.

And since science is based on data, Pivotal has heavily invested in becoming a data-driven CRO that prioritizes mobility. Thus, we dive deep into clinical trials by leveraging our near real-time advance analytics and visualization platform and are able to discover data-driven insights and anticipate trials´ risks and predict their impact. We are a technology-savvy organization, and this has made us an efficient, agile and resilient company that is very focused on our customers.

Pivotal counts, today, with as many as 200 employees and operating in more than 22 countries. We have built focused specialization across all therapeutic areas and founded a strong oncology, hemato-oncology, rare diseases, innovative therapies, and early phases hub that enable us to tackle our customers’ most difficult challenges. After 20 years of hands-on experience, we master clinical research.

Our culture

At Pivotal we’d like to build a better clinical research environment – we deliver quality-but also have bet to build a great firm that attracts and retains exceptional people – creating leaders and embracing and exploiting diversity as an asset-. Pivotal’s values – Trust; Impact; Meticulous; Unite; Care- are behind this all and behind all of our actions.

Our approach to clinical trials

We strive to be our clients’ preferred full-service, clinical-development partner CRO and for this, we aim to approach the performance of clinical trials in our own “Pivotal’s way” – and have then developed our own culture and working methodology, very much based on a “hands-on” attitude.

At Pivotal we aim 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 while keeping our customers in the center of our work and listening to their inputs and putting ourselves in their position to just better understand their needs and trying to become, simply, an extension of their own team. We deliver daily to our clients, and make sure every deliverable, document, slide or message is clear, adds value and, eventually, reduces time to market.

On the other hand, when projects turn “live”, we try to stay true to our scientific soul and attempt to make all our decisions based on data, while anticipating all potential hurdles that may arise rather than simply reacting to them.

Our solution for Biotechs

Over the last years, Biotechs have burst with power into the world of drug (and other medical products) development. And Biotechs do bring science in their DNA; just as we do at Pivotal. Or in other words: Pivotal can think with a Biotech’s mind. And not only from such scientific perspective, but also from a more corporative angle that has allowed Pivotal to understand all constraints that a Biotech may have to face when setting up a clinical trial – e.g. limited in-house resources, complex regulatory landscapes, challenging access to funds-. At the end of the day, our purpose is to become part of their team.

Our clinical technology

Pivotal pushes for science, and science is based on data. We believe that, when used in the right way, data and analytics can create competitive advantage, re-engineer processes and enhance risk controls. At Pivotal we have built a technological architecture that supports change, that is modifiable, scalable, efficient, secure and stable.

Other Information

Pivotal provides full Contract Research Organization (CRO) services, but yet we are able to offer our clients a variety of contracting models, from single source to full service, helping to create flexible relationships with our clients, and allowing a selection of those services actually needed on a case-by-case basis.

Our portfolio of services includes:

• Regulatory Affairs – We are local experts, and we help to pave the regulatory way
• Clinical Operations – We provide on the ground targeted support to the clinical sites
• Patient Journey – We are patient-centric, and this is part of our DNA
• Data Management – We count with “Data Lovers”, and we leverage the value beyond the numbers
• Biostatistics – We understand study data, we deliver the right deliverable
• Medical Services – We help transform science into new therapies
• Pharmacovigilance – We have a proactive approach which enhances safety risk control
• Quality Assurance – We strive for excellence in everything we deliver

Staff Experience

Our teams

All our staff members – from Operational to Medical to Management and all other teams- are energetic, clearly client-oriented and have all a deep knowledge of their respective responsibility areas, combined with an extensive experience in the setup, execution and/or management of clinical research projects and a truly commitment with “delivering quality”. And certainly, all committed with and passionate for clinical research and bringing medical solutions much closer to patients.

Our staff has transited through some 525 clinical research projects that have involved the handling and management of nearly 40,000 patients and 6,500 clinical sites in a variety of interventional clinical research phases and indications, and with quite diverse medicinal products and nearly 65,000 patients and 10,000 sites in NIS (Non-Interventional Studies).

All in all, a robust team to rely on.

Research Experience

As already mentioned, we provide our clients with a robust and ample experience background – that includes all the learnings taken from each single project we have been involved in- and which ranges from FIH clinical research projects to late Phase 4 trials or to post-marketing NIS studies. And across all these projects our teams have dealt with research with “classical drugs”, but also with that of novel therapies – like biological entities or advanced gene and cell therapies- or other products like medical devices, each with its particularities, from both regulatory and operational perspectives. These projects were most aimed for treatment, but also include some for diagnostic purposes, such as radiopharmaceuticals.

When looking closer to and dissecting Pivotal’s experience analysis confirms our solid experience in the “Oncology” and “Hemato-oncology” areas – in which we are particularly strong with approx. 275 projects completed- but also in the very much ample “Internal Medicine” area – which encompasses more than 200 projects covering several distinct specialties from Infectious/Vaccines/COVID-19 to cardio- and cerebro-vascular to endocrinology and diabetes to neurological disorders, and many others. Or in a list-format those all include:

• Oncology
• Hematology and Hemato-Oncology
• Immune-Based Diseases
• Obstetrics and Gynecology
• Surgery, Anesthesiology and ICU
• Dermatology
• Respiratory and Allergology
• Cardio- and Cerebro-vascular
• Infectious Diseases, Vaccination and COVID-19
• Gastroenterology, Hepatology and Nephrology
• Endocrinology and Diabetes
• Neurology
• Rheumatology
• Others

Yet, and when looking at our experience from an alternative perspective, we shall mention other projects classified under a different rationale that include projects connected to:

• Advanced Innovative Gene and Cell Therapies
• Rare & Orphan Diseases
• Pediatrics
• Medical Devices
• Trials needing a “rescue”