Biometrics

Because each client has unique needs, we offer unique solutions—one size doesn’t fit all. This uniqueness is why PRA has structured our Biometrics organization to be flexible and scalable: allowing us to be dynamic and support our clients in a way that best meets their personal needs while managing costs.

At PRA, our Biometrics organization starts with the end in mind, tracking backwards along the regulatory pathway to ensure the data are reported, displayed and captured in the most appropriate manner to support our sponsor’s development process. We are an effective & efficient multidisciplinary team; an extension of our sponsor’s capabilities.

Jesse Kooker, MPH – Senior Vice President, Global Biometrics

Biometrics Global Presence Map

01
Our Structure

At PRA, Biometrics forms a centralized, global model that integrates Portfolio Management, Biostatistics and Programming, Data Operations, and Medical Writing and Publishing. Our team of top industry experts operates across all phases and all PRA divisions making it easy for PRA to customize our Biometrics model to be client specific and to offer synergies and cost-effective solutions.

Our-Structure

Improved communication and increased accountability ensure that the project stays on track, on time, and within budget.

PRA’s project team structure improves accountability of deliverables and allows for improved peer-to-peer communication—between the sponsor’s and PRA’s project managers—ensuring more effective communication and understanding among the project team members.

For each project, PRA builds a Biometrics team of technological experts in drug research who have strong foundations in data management, biostatistics, programming, and medical writing. Our experts work closely with clients to develop flexible, real-world solutions that comply with global data and reporting requirements.

Lead data managers, biostatisticians and medical writers are accountable for the Biometrics deliverables produced by the functions under their leadership. Supported by the leads, the project manager is accountable for successfully harmonizing deliverables across the entire project team.

Our-Structure

02
Our Solutions

Improved communication and increased accountability ensure that the project stays on track, on time, and within budget. PRA’s project team structure improves accountability of deliverables and allows for improved peer-to-peer communication—between the sponsor’s and PRA’s project managers—ensuring more effective communication and understanding among the project team members. For each project, PRA builds a Biometrics team of technological experts in drug research who have strong foundations in data management, biostatistics, programming, and medical writing. Our experts work closely with clients to develop flexible, real-world solutions that comply with global data and reporting requirements. Lead data managers, biostatisticians and medical writers are accountable for the Biometrics deliverables produced by the functions under their leadership. Supported by the leads, the project manager is accountable for successfully harmonizing deliverables across the entire project team. PRA-Biometrics-Solutions

03
Our Technology

Replacing time-consuming work with an efficient, repeatable model. At PRA, our Biometrics team uses comprehensive and flexible systems replacing traditional, manually programmed processes with automated, reusable programs for data extraction, data transformation, statistical reporting and electronic publishing resulting in significant process savings, streamlined documentation, and improved quality. We are consistently serving the market with innovative delivery platforms to enhance the effectiveness and efficiency of our deliverables. Designed to work with Clinical Data Interchange Standards Consortium (CDISC) models as well as PRA and client-specified standards, our propriety technology automates tasks that have previously involved researchers and biostatisticians manually writing and validating programs.

Our Technology