Pivotal
Technology-Driven Clinical CRO

In a pharmaceutical battlefield where organizations are waging war for drug supremacy, Contract Research Organizations (CROs) play a major role in streamlining the end-to-end processes ranging from pre-clinical development to post-marketing research. Perfecting this role, Pivotal is a CRO that applies its therapeutic, scientific, and analytical expertise to help clients tackle the challenges of drug development. Founded in 2001, Pivotal is a 200-strong, privately held, European CRO that has a long vision towards the future, adheres to its commitments with its clients and plans for organic and stable corporate growth strategies. One of Pivotal’s major area of investment is technology. “Pivotal aims to become a digital and data-driven CRO that provides end-to-end data and process integration, allows for real time monitoring and brings together teams and resources in a single, collaborative and modern workspace. And this is built under a secured role-based user access management which will ultimately raise the clinical trial efficiency and data quality,” says Dr.Ibrahim Farr, Chairman and CEO of Pivotal.

In the present day situation, biotechnology companies face the challenge of shortage of medical departments. In this scenario, Pivotal’s strong and diverse medical team comprising specialists in oncology, hemato-oncology, clinical immunology, internal medicine, pharmaceutical medicine and cardiology differentiates Pivotal from other CROs. With such an added value expertise Pivotal helps clients monitor projects from a medical standpoint, which in turn increases the certitude of the studies and allows Pivotal to act as “co-thinkers” to its clients as well as being “the doers”.

Pivotal offers full services capabilities ranging from regulatory and start-up to clinical operations and project management, data management, biostatistics, medical monitoring, pharmacovigilance, and audits services, among others. While these offerings qualify Pivotal to be a promising clinical CRO, the capability to provide regulatory advisory throughout all EU countries enhances the company’s value proposition in the market.

With medical expertise in our DNA, we aim to use technology to set new benchmarks and standards in the industry

The regulatory strategy led by a team comprised of local regulatory experts with a Europe-wide reach and supported by the clinical monitors will develop a comprehensive and fail-safe regulatory approval plan. Additionally, Pivotal’s team alleviates Sponsors´ concerns pertaining to the European General Data Protection Regulation (GDPR), leveraging in-depth knowledge and adherence to GDPR.

Pivotal also has a strong team of clinical programmers and data managers who are trained on standards such as CDISCSDTM and ADam. With advanced data management technology and remote data capture, the company operates as a functional solutions provider whose offerings can be implemented as a package or as isolated modules.

Pivotal’s ability to ensure the best quality of services and outcomes has helped the organization to achieve organic growth and ensure high client retention rate. Pivotal has worked across different offerings with some 197 clients, mostly major Pharma as well as Biotech Companies, based across the Atlantic. In the majority of these projects, the clinical operations´ team has delivered quality patients´ enrolment across the clinical trial´s value chain, with repeat business accounting for about 75%. Pivotal has also performed many trials in association with major cooperative groups, especially in Oncology, some of them had eventually been converted into pivotal registrational trials. Also, the Company has had experience in rescuing 2-3 faltering trials per annum from other regional or global CROs.

The Madrid-based Pivotal began collaborating with firms outside Spain in 2008 and in the last decade, the CRO has spread wings across the European Union, establishing itself with staff on the ground across 23 countries where the company intends to strengthen still further its foothold. Pivotal is strongly investing in areas such as unified communications, cloud computing and modern collaborative workspaces. Pivotal fosters to become a technologically agile and data-driven company with a single and centralized business intelligence and analytics platform to connect to. “With medical expertise in our DNA, we aim to use technology to set new benchmarks and standards in the industry,” affirms Dr. Farr.