admin Clinical Research Organisations (CROs) are indispensable for advancing medical science in the dynamic field of healthcare and drug development. These organisations specialise in managing the complex, multifaceted process of clinical trials, which are essential for developing new treatments and therapies. Clinical trials are designed to rigorously evaluate the safety, efficacy, and overall benefits of new medical interventions through a series of carefully planned phases.
CROs bring together scientific expertise, regulatory knowledge, and advanced technological capabilities to navigate the intricacies of clinical research. They provide comprehensive services that include study design, regulatory compliance, patient recruitment, pharmacovigilance, medical services, data management, and statistical analysis. The integration of cutting-edge technologies, such as real-time data analytics and risk-based monitoring systems, enhances the efficiency and accuracy of trials.
The need for CROs has grown as the demand for innovative treatments increases and regulatory requirements become more stringent. When it comes to partnering with the most customer centric CROs, Pivotal is the name trusted by most. Founded in 2001 by Dr. Ibrahim Farr, Pivotal emerged from an environment rich in scientific expertise and drive. Dr. Farr’s vision was to implement scientific strategies and best practices that enhance the efficiency of clinical trials and maximise the value chain of clients’ drug development programs. With a workforce of approximately 200 employees operating in over 20 countries, Pivotal has developed focused specialisation across all therapeutic areas and regions. The company has established a strong hub for innovative therapies and early-phase trials, enabling it to tackle the most challenging projects.
After nearly 23 years of hands-on experience, Pivotal has mastered the intricacies of clinical research. The company envisions a future driven by digital and data-enabled growth. Leveraging its proprietary advanced insights platform, Danah, Pivotal discovers data-driven insights to anticipate trial risks and predict their impact. This makes Pivotal an efficient, agile, and resilient organisation, deeply committed to its customers. As a technology-savvy entity, Pivotal’s innovative organisational model is connected with the clinical research and technology ecosystem, ensuring it remains scientifically, medically, and data-driven, as well as agile and customer-centric.
Today, Pivotal has emerged as the most trusted European CRO covering also the Middle East. Pivotal covers all European countries with staff on the ground, as well as globally via trusted partners ensuring comprehensive coverage and regional expertise. This regional structure allows Pivotal to manage clinical trials effectively across diverse geographies, adapting to local regulations and cultural nuances.
A Legacy of Excellence
“We have a tried-and-tested model which we call the “Pivotal Partnership Way” which has been running successfully and productively for more than 17 years”
– Lourdes Huarte
Pivotal’s inception was driven by two key principles: to be a medically and scientifically-driven company, and to leverage data and technology in groundbreaking ways. From its beginnings, the company has grown organically across Europe and the Middle East, establishing a robust presence and partnering with select CROs globally to conduct comprehensive clinical trials. This expansive reach is underpinned by a tried-and-tested model, aptly named the “Pivotal Partnership Way,” which has been successfully operational for over 17 years. As a full-service CRO, Pivotal offers comprehensive capabilities encompassing Regulatory and Clinical Operations, Data Science and Management, Biostatistics, Medical Monitoring, Pharmacovigilance, and Quality Assurance & Compliance.
The second cornerstone of Pivotal’s philosophy is becoming a data-driven, tech-savvy organisation. Pivotal’s in-house advanced proprietary platform, Danah, is an embodiment of this philosophy. Danah is a platform created to track and manage clinical trial data. Danah includes functionalities such as CTMS, eTMF, training modules, and provides valuable operational and clinical insights, along with Risk-Based Quality Management (RBQM). This technological prowess enables Pivotal to efficiently manage trials and deliver high-quality results.
Upholding Core Values Through Action
Central to Pivotal’s operations is a mission to be the most customer-centric CRO on earth. This ambitious vision is realised through the delivery of faster, smarter, scientific, and affordable solutions, aimed at building a better clinical research world. The company’s values—Trust, Impact, Meticulousness, Unity, and Care—serve as guiding principles, influencing every decision and action within the organisation. These values are not mere words but the foundation upon which Pivotal’s esteemed reputation is built.
Pivotal brings together people with shared values, drawing inspiration from patients’ lives, and ensuring integrity in all actions. The company has been successful in generating trust through transparency and delivering as agreed. This trust is maintained as one of the single most important ingredients in all clinical trials. Instead of being reactive, Pivotal remains predictive and proactive. The company makes data-based decisions, prioritising work that impacts clients’ performance indicators. Striving for quality in every deliverable, Pivotal emphasises clinical quality by design and risk management. At the same time, Pivotal believes in sharing knowledge within the clinical research community and understanding that teamwork amplifies individual contributions. These ‘North Star’ values of Pivotal have become the bedrock of the organisation, guiding every aspect of action and decision-making process within it.
Leaders at the Helm
The strength of any organisation lies in its leadership, and Pivotal is no exception. The company’s three Senior Vice Presidents (SVPs) bring a wealth of experience and expertise, driving innovation and maintaining the highest standards of quality.
Serving as the SVP Corporate Development & Finance, Lidia Farr is a healthcare and life sciences executive with over a decade of experience. Joining Pivotal in 2009, she has been instrumental in implementing innovative technological solutions that uncover data-driven insights, anticipate trial risks, and predict their impact. Lidia holds a Master of Science degree in Electrical Engineering from ICAI University in Madrid and completed her studies at ENSTA University in Paris. Her prior experience at J.P. Morgan in the Merger and Acquisitions department within the Healthcare team in London and the Iberian team in Madrid further enhances her strategic acumen.
With over three decades of experience, José Javier García is a cornerstone of Pivotal, serving as its SVP Clinical Data Science & Biostatistics. Holding a Medical Degree from Autónoma University in Madrid and an Expert Certification in Statistical Biological Models from Complutense University, he has a distinguished career marked by significant contributions to biostatistics and clinical data science. His roles included serving as Vice-President of the Spanish Association of Biostatisticians (ABCif) and founding the Spanish CRO Association (AECIC). Additionally, José Javier is a Professor of Epidemiology and Biostatistics, reflecting his deep commitment to academia and industry.
A pharmacist by training with a PhD with over 30 years of experience, Lourdes Huarte’s career in the pharmaceutical industry is both extensive and diverse. Starting as a Clinical Research Associate, she has evolved through various roles, including leading a team of 40 at Aventis and heading the Clinical Research Unit in Portugal. Joining Pivotal in 2006, Lourdes now leads a team of 110 associates as the SVP Regulatory & Clinical Operations for the company. Her primary role is to ensure the delivery of high-quality clinical trials. Her expertise is complemented by an MBA, providing her with a holistic view of corporate strategy and development.
Gaining Customer Loyalty Through Trust and Transparency
Trust is the cornerstone of Pivotal’s relationships with its clients. The company’s approach to building and maintaining trust involves a personalised and proactive strategy that emphasises flexibility, expertise, communication, and quality. The company considers transparency as a cornerstone of all its operations that is essential for building trust and ensuring ethical conduct. This transparency is achieved through several key practices, chief among them being open and direct communication with clients. Pivotal also provides regular updates on project progress, including clear, accurate, and timely information about milestones, enrolment status, and potential risks. The company is proactive in proposing alternatives and solutions to any issues that arise. Establishing open communication channels allows clients to ask questions, raise concerns, and provide feedback. Pivotal’s commitment to responding promptly and honestly to inquiries and addressing discrepancies transparently further reinforces trust, underscoring transparency as a fundamental value. “By consistently delivering a high-quality service and permanent support, we aim to become a real trusted partner and not a mere provider”, adds Lourdes.
Becoming a Trusted Brand
“Building strong and long-lasting relationships with our clients is also a priority for us”
– Lourdes Huarte
The path to becoming a trusted brand is not always simple and easy. Brands can only claim a market niche by winning customer approvals and implementing policies that benefit clients. Pivotal’s unique approach has helped the company emerge as a trusted brand partner. At Pivotal, three core elements drive success: customer satisfaction through excellence, a foundation of core values and honesty, and the delivery of quality results. Their commitment to these principles ensures that the brand not only meets but exceeds client expectations, fosters a positive and ethical workplace, and consistently produces high-quality deliverables. These essentials form the bedrock of Pivotal’s reputation as a trusted leader in clinical research. This unique approach is characterised by:
- Personalised Solutions
Each clinical trial presents its own set of challenges and requirements, and Pivotal excels in developing tailored solutions to meet these needs. By working closely with clients, the company ensures that every aspect of the trial is customised to achieve the best possible outcomes.
- Flexibility and Adaptability
Flexibility and adaptability are the cornerstones of an ever-evolving world of clinical development. Pivotal’s ability to respond quickly to changing circumstances—whether adjusting timelines, reallocating resources, or revisiting strategies—ensures that trials proceed smoothly and efficiently.
- Expert and Professional Support
Pivotal’s team comprises experienced professionals who are experts in their respective fields. From providing initial advice on study design to navigating complex regulatory requirements, clients can rely on Pivotal for knowledgeable and reliable support throughout the trial lifecycle.
- Proactive Communication
Effective communication is vital in clinical research, and Pivotal prioritises keeping clients informed at every stage. Regular updates on progress, milestones, and any emerging challenges ensure that clients feel supported and involved throughout the trial.
Commitment to Quality and Compliance
Pivotal adheres to current ICH E6 GCP and all applicable regulations and guidelines, ensuring the highest standards of quality and compliance. The company’s Quality Management system prioritises human subject protection and the reliability of study results. Utilising a risk-based approach, Pivotal effectively identifies, analyses, and responds to potential risks in clinical studies. This rigorous compliance framework is validated by the company’s impeccable history of numerous third-party audits and Competent Authority inspections, with no warning letters or FDA 483 Forms issued. The consistent repeat business from clients and their references further testify to Pivotal’s unwavering commitment to regulatory and clinical excellence.
Staying Ahead of the Market Curve
Pivotal employs a comprehensive approach to stay current with industry trends and emerging technologies. This strategy involves dedicating significant time to research and study industry and market trends. The Corporate team, led by the SVP of Corporate Development, actively engages in this research. Upper management is equally committed, frequently reading industry publications and reports. Continuous learning and the implementation of best practices are promoted within all teams. Participation in conferences, seminars, and congresses provides valuable opportunities for networking, knowledge sharing, and exposure to new ideas. As a tech-savvy company, Pivotal invests in the development of innovative technologies, such as the proprietary platform Danah. Ongoing training ensures that team members possess the skills and knowledge to remain at the forefront of their fields. Additionally, Pivotal leverages external expertise by consulting with industry experts and advisors, gaining valuable insights into emerging trends and technologies.
Fostering a Positive Corporate Culture
Pivotal’s positive and inclusive corporate culture is a testament to its commitment to employee well-being. Pivotal’s management maintains open lines of communication among teams to actively listen to employees. By providing value to this feedback, the company creates a culture of transparency and trust. Additionally, the management team at Pivotal understands the importance of work-life balance and offers flexible work arrangements, including remote work options, flexible hours, and generous holiday policies. These initiatives help employees maintain a healthy balance between their professional and personal lives. Regular employee surveys provide valuable insights into the needs and concerns of the workforce. By analysing this feedback and implementing appropriate actions, Pivotal ensures that its employees feel valued and supported.
Pivotal aims to foster a positive and helpful work culture right from the first day of a new recruit. A comprehensive onboarding process helps new hires transition smoothly into their roles. Pivotal’s “Buddy Programme” pairs new employees with experienced colleagues, providing mentorship and support to help them integrate into the company culture. At Pivotal, every new employee is offered comprehensive training. “Whenever a new employee joins the company, we encourage asking as many questions as needed. There are no silly questions, and it is better to ask first rather than risk doing things incorrectly.,” notes Lourdes. The organisation emphasises continuous learning, information sharing, and open communication to foster innovation. New employees are encouraged to think “out of the box” and are supported through various training programmes and opportunities to attend industry congresses. This approach enhances their skills and contributes to Pivotal’s commitment to innovation.
Holding onto the Most Trusted Brand Title
Looking ahead, Pivotal envisions continuing its journey as the most customer-centric CRO globally. The company’s long-term goals include maintaining its position at the forefront of the clinical research industry by delivering faster, smarter, scientific, and affordable solutions.
Magazine 
