Center InformationNatalia Farr Communications Manager Pivotal S.L.U. HQ: Calle Gobelas 19, La Florida Madrid, Spain 28023 Phone: 0034 679 488 022 Email: email@example.com
Currently Enrolling Trials
Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognized the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the "doers" but also as the “co-thinkers” for their clients, through its strategic scientific advice. To date, we are the trusted advisor and counselor for many companies to deliver maximum value in their drug development programs. We are a leading privately-held European CRO and, since inception, we have experienced a fast and steady organic growth. We are currently employing some 200 cross-functional professionals.
Our clients’ portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, and we have long-standing relations with >200 clients. Pivotal has extensive experience across major therapeutic areas and phases from phase I to IV. Our highly customized teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights, while maintaining high quality standards. Additionally, we have built a strong oncology, innovative therapies, rare diseases and early phases hub that enables us to tackle our customers most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our client’s preferred outsourcing solution partner.
In an increasingly complex environment, Pivotal’s professionals apply their deep therapeutic, scientific and analytical expertise to help our customers navigate the challenges that arise during all the phases (clinical trials and non-interventional studies included) of the clinical development value chain and processes with IMPs, medical devices, diagnostics and nutritional products. Our goal is to provide high quality services across the entire spectrum of clinical research development, especially early phases. From start-up to completion of the final study report, performance is monitored regularly and measured against contractual timelines and budgets. Our clients enjoy the benefits of Pivotal’s senior management hands-on environment, operational teams working on the ground with the clinical sites and cost-effective deliverables.
By applying a variety of outsourcing models from single source to full service, Pivotal builds a flexible client relationship, and ensures a single-source provider.
SERVICES WE PROVIDE:
- Regulatory Affairs and Study Start-Up
- Legal Representation for non-EU based Companies
- Clinical Trial Monitoring and Sites/Project Management
- Patient empowerment and recruitment services via our proprietary C-Lys platform
- Data Management and Biostatistics
- Medical Monitoring and Medical Writing
- Quality Assurance, Compliance and Auditing
- Biotech Consultancy and Scientific Development
OUTSTANDING ADDED VALUES:
Our multi-specialty medical staff is the backbone of every trial conducted since they bring in-depth therapeutic expertise and strategic advice into the drug development programs and help biotech companies in supporting their scientific development programs. Our senior management is approachable and directly involved in the clinical studies to help achieve more predictable deliverables.
Our operational team is energetic, client-oriented and deeply knowledgeable in managing and executing clinical trials and studies at the highest quality standards Our target is to deliver cost-effective solutions for our clients and not overburden them with the challenging overhead costs
Our team is full of driven and cross-functional people with an extensive experience in executing and managing clinical trials in all phases from I to IV, as well as observational studies, and covering most of the main and more complex therapeutic areas. Our professionals have a deep and broad experience in all stages of the clinical research development process and value chain, from study start-up through delivery of the final report.
The diversity of our employees’ background provides Pivotal the range of expertise we require to tackle our clients’ most complex trials needs. Our people are all bound by a shared passion for taking on immense challenges that matter to our clients and working on the ground with the clinical sites. Our clients tell us that we are down-to-earth and approachable.
Our staff has a pragmatic quality approach that focuses on getting the job done and turning decisions into actions. We build the internal capabilities required for our clients to achieve successful results with high quality standards. Real learning and growing happens on the job, but at Pivotal we also believe in the continued training and therefore, we invest significant time and effort in developing and renewing our staff´s knowledge. This offers unique perspectives and insights to our clients.
Our Quality System
Pivotal has an independent Quality Assurance & Compliance Unit that reports directly to the CEO and that has built over years of experience a solid quality system to ensure the highest standards. This is accomplished by the following key elements: Quality Manual, Standard Operating Procedures, systems and project yearly internal audits and continuous staff training. We proud ourselves for being an audit and inspection-ready organization. Pivotal maintains its own corporate Standard Operating Procedures (SOPs) which govern all trial operations to ensure that activities are controlled, documented and conform to GCPs. Our SOPs were designed and are monitored and regularly updated by a separate team with deep clinical expertise. When necessary, local specific and study-specific procedures may be prepared. Also, we have the flexibility to operate with our clients’ SOPs when requested. All our SOPs are available for reviewing and auditing.
Pivotal has assembled a strong leadership team that combines unrivaled operational expertise and management experience with a global background. Pivotal’s leadership team contributes to managing growth and direction of the company and is highly committed to the company’s long-term goal and to foster Pivotal’s entrepreneurial culture. The management team at Pivotal has a hands-on experience and attitude and is approachable and down to earth.
Vision, Mission and Values
We strive to be our clients’ preferred full service clinical development partner in Europe
We are experts in key and challenging therapeutic areas while remaining focused in oncology and hematology, innovative therapies, rare diseases and medical devices
We endeavor to become the place to work, our people set us apart
We earn our customers’ trust by performing their R&D programs at the highest quality standards
We truly become a valuable extension of our client’s team
Our values make Pivotal a special company and help to build an enduring firm that attracts, develops and retain exceptional people. Our core values are:
- One team attitude. The more minds that contribute the better results
- Client focused and responsiveness. Client comes first, this means we deliver rapidly and with more value than expected
- True flexibility. Openness to adapt to our clients most tailored needs
- Absolute integrity. Behave as professionals. We extend trust, respect, and support in all our interactions
- Commitment to quality. The cornerstone of Pivotal’s success
- To become the place to work. We have passion for our people