Clinipace: Global, Full- Service Contract Research Organization

Clinipace: Global, Full- Service Contract Research Organization

Strategic partnerships between pharmaceutical organizations and their contract research organization (CRO) are no longer exclusive to the bigger firms and its massive funding. Small or mid scaled research firms are looking for highly strategic CRO partnerships, wherein they can capitalize on the capabilities of the CRO and instead focus on their own core strengthening. Clinipace is an e-clinical solution that delivers collaborated, controlled and guided contract research for firms with limited resources, requiring regulated results, and looking for commercial success at the end of their trials. “As Clinipace grows, we are committed to making investments that will put us in position to bring forward the best clinical development services and solutions based on client needs,” says Jason Monteleone, CEO of Clinipace.

With therapeutic expertise in gastroenterology, Nephrology and Urology, Oncology, women’s health, Clinipace also offers assistance in highly nuanced field of rare diseases. The development and regulatory team understands the competitive research environment and it’s time constraints. With state-of-the-art technology, Clinipace simplifies and streamlines the research across all phases while being flexible, therefore adapting to the needs of the entire registration process.

Clinipace provides personalized services and solutions, local regulatory expertise and therapeutic leadership, which is impossible to replicate in a traditional CRO environment. With a team of qualified scientists and technicians, Clinipace provides Phase I-IV clinical research and development across 40 countries. So it helps in conducting successful multinational studies, by gaining operational proficiencies and ensuring consistencies across local regulatory requirements, treatment landscapes and varying standards of care. Clinipace’s Clarity Stack clinical technologies simplifies data collection, providing electronic data captured (ETC) to clinical trial management system (CTMS) integration through a continuous flow of integrated information and securing a real-time view of the research.

During the clinical development phase (Phase I-III), the project management team of Clinipace, coordinates all aspects of the study whereas the medical, operations and regulatory experts execute the programs.

As Clinipace grows, we are committed to making investments that will put us in position to bring forward the best clinical development services and solutions based on client needs,” says Jason Monteleone, CEO of Clinipace

The team is dedicated in achieving success for the firm while being compliant with the local regulatory system. Once the project reaches to its phase IV, Clinipace provides assistance with late-phase post marketing studies along with budget impact modeling. Clinipace has centralized North America, European and Asian hubs to handle the regulatory needs across any region.

Data collection from silo operated e-clinical systems, and reporting is a cumbersome process in a traditional CRO environment. Clinipace solves this issue with its very own interoperable system called Clarity Stack, powered by Adaptive Clinical. Clinipace uses this for early identification of issues, reviewing project progress and analyzing patient data performance. Clinipace is agnostic compatible, so the firm can either use industry leading technology from Clinipaces’ trusted partners, or use their own system. A dynamic dashboard surveillance system helps in easy analysis and interpretation using any smart device. Clarity Stack provides real-time data reporting with standardized data relationships and easy implementation techniques. For projects which require expert level supervision and guidance, Clinipace provides functional servicing with a team of their clinical research leaders.

Clinical research is becoming more complex, requiring increasingly specialized knowledge, tools and resources. Clinipace has completed more than 1500 contract researches and 1500 regulatory drug or medical device development projects across a number of therapeutic areas. With the motto of ‘Challenge Accepted’, Clinipace is imbibing the latest technology and expertise into the field of clinical research. In 2011 it was awarded the number one spot on ‘The Triangle Business Journal’ fast 50 spot and is continuing to pick up more accolades.
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Morrisville, NC

Jason Monteleone, CEO

At Clinipace, they take pride in building strong relationships and doing what it takes to deliver clinical development services and solutions that successfully moves the drug candidate from bench to bedside. They are committed to conducting regulatory and clinical development programs to the highest levels of quality and efficiency and also strive to improve the way clinical research is performed and to advance the future of health care with their unique approach and cutting-edge technology. Clinipace is fully invested in the outcomes of the patient’s trials