What we do

We provide full clinical research services

Regulatory Affairs

We are local experts, we pave the way

In an increasingly regulated, complex and changing environment, a sound regulatory approval strategy is paramount to any trial’s success. Our staff are local experts in the culture and expectations of the regions, and this, paired with a broad therapeutic and regulatory experience, allows to accelerate trial approval.

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Clinical Operations

We provide on the ground targeted support to the clinical sites

It takes both technology and deep clinical expertise to enable data-driven decisions in clinical monitoring. Pivotal’s clinical trial intelligence solution consolidates data on a single platform helping our teams transform insights into actions, anticipate trial risks and predicts the impact. We identify and manage key risk indicators to reduce danger and improve study efficiency.

Pivotal’s project managers will lead and coach the team throughout the clinical study to achieve the maximum potential. Our project leader will power the potential of our clinical trial intelligence solution to identify and remove any significant impediment for the study. The team, our CRAs, will work on the ground with the clinical sites to provide targeted site support that improves study compliance and site engagement.

Pivotal’s clinical team is full of energy-driven and cross-functional people with a profound experience in executing and managing clinical trials in all phases (I to IV) and covering most of the leading and more complex therapeutic areas.

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Patients

Patient Journey

We are patient-centric, is part of our DNA

We aim to improve patient outcomes, and patient-centered thinking is an essential part of achieving that. Patients´view, preferences and experiences should drive clinical trial design. Our patient´s centered services leverage the patient´s perspective to enhance awareness, recruitment and retention. C-Lys is a cloud-based patient´s management platform that is fully customizable to your study and provides a range of automation and survey solutions to manage patient recruitment efficiently.

Our Patient Journey team combines expertise in digital marketing, therapeutic disease and clinical trial regulation, and it adopts an agile philosophy for the project´s execution.

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Years of proximity

Data Management

Data lovers, we leverage the value beyond the numbers

We provide flexible and accurate data management solutions that ensure integrity, accountability and speed. From database build to database lock, Pivotal provides clean data in real-time. We use the latest EDC technology to capture, integrate and standardize clinical data. Our data managers and programmers transform data into insights. We have extensive experience across a broad range of therapeutic areas and different clinical phases, from Phase I to IV.

Pivotal’ s data management team is seasoned in information technology and pharmaceutical research data analysis. Many hold advanced degrees in math, science, or computer science.

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Remote Data Captures

Biostatistics

We understand study data,
we deliver the right outcome

In an increasingly regulated environment, we enhance biostatisticians’ job as they play a crucial role in accelerating timelines and improving the quality of submissions. Our biostatisticians use the latest technology to help you in the study design; they provide regulatory support and effective analysis and reporting. At Pivotal, we pride ourselves in building a biostatisticians team with in-depth regulatory knowledge and specific therapeutic expertise, matching our customers’ needs, to providing accuracy, speed and flexibility with study reporting. Our rigorous validation and quality control processes will eliminate the need for corrections and ensure accurate reports.

Our biostatisticians´ team is seasoned in information technology and pharmaceutical research data analysis. Many hold advanced degrees in maths, science, or computer science.

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Medical Services

We help transform science into new therapies

We have a very talented medical team. Our medics bring to the table their solid scientific background, medical expertise and connections in the scientific community.

We will help you find the most direct path from science to novel treatments through our therapeutic centers of excellence. Pivotal connects your clinical study or program with a medical team with extensive clinical trial experience and deep therapeutic insight. We provide flexible solutions from protocol conception and expert medical monitoring services to writing and reviewing final study reports and publications.

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Pharmacovigilance

We have a proactive approach which enhances safety risk control

In a time of unprecedented acceleration in clinical development and ever-changing regulatory landscape, Pivotal will keep you in control of your drug safety. Our proactive approach allows us to get ahead of safety problems and maintain trial integrity and a lower risk profile. We use the latest Oracle Argus technology and leverage our near real time analytics platform to identify safety trends. To enhance risk control.

Our staff are highly skilled medical and Eudravigilance-certified safety professionals fully versed in the regulatory requirements and with deep therapeutic expertise.

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Quality Assurance

We strive for excellence in everything we deliver

Our QA team aspires to excellence and ensures that our teams perform to the highest standards. This experience is leveraged in our quality assurance service offerings. We help customers to develop or update their quality systems and procedures and to conduct 3rd party audits.

Pivotal’s QA team is assembled by professionals with extensive clinical research experience and knowledge of the GCP guidelines and regulations. Our team is versed in 21 CFR Part 11 compliance and uses a controlled Agile methodology for software development and validation.

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