Parexel adopts platform to handle post-approval trials

By Nick Taylor

- Last updated on GMT

Related tags: Clinical research

Parexel has implemented a web-based system to help it handle the increase in data volumes that has resulted from the expansion in number, size and complexity of post-approval studies.

Regulators and payers are increasingly requesting long-term safety and health outcomes data and this is driving growth in post-approval studies. In turn, this has created a need for new technology platforms.

A variety of late phase studies, including observational studies and patient registries, are being used as either primary or adjunct vehicles for pharmacovigilance and health evaluation activities​”, explained Carol Collins, corporate vice president and worldwide head of PACE at Parexel.

To manage the increased data throughput volumes resulting from the growth in post-approval studies, while keeping costs down, Parexel has adopted a new web-based technology platform.

The system integrates strategies and processes developed by Parexel’s PACE (peri approval clinical excellence) team and eClinical technology from Perceptive Informatics, a subsidiary of the contract research organisation (CRO).

Adoption of the system allows Parexel to produce higher quality data at a significantly lower cost per patient. Furthermore, tools such as electronic data capture (EDC) and electronic patient reported outcomes (ePRO) work in conjunction with the system to improve data integration.

Parexel added that randomisation and trial supply management (RTSM) and clinical trial management systems (CTMS) can also be incorporated into the post-approval platform.

The system provides centralised access to data, including site, patient and clinical supply information. Additional features include enhanced reporting capabilities, automated cues for unique late phase site requirements and functionality for site self-registration and management.

Related news

Show more

Related products

show more

Local Lab Data Management

Local Lab Data Management

Q2 Solutions | 01-Jul-2020 | Technical / White Paper

When a clinical trial requires local or point-of-care laboratory testing, managing the resulting data can be a significant burden to both the sponsor and...

Laboratory Solutions for COVID-19 Clinical Trials

Laboratory Solutions for COVID-19 Clinical Trials

Q2 Solutions | 10-Jun-2020 | Clinical Study

As a leading laboratory services organization for trials across the globe, we are proud to partner with clients to support COVID-19 clinical trials. Our...

Parents as Gatekeepers for Children with Cancer

Parents as Gatekeepers for Children with Cancer

PRA Health Sciences | 08-Jun-2020 | Technical / White Paper

The RACE for Children Act will require new drugs intended for adult cancer treatment to also be studied in pediatric cancers when the molecular target...

RACE Act Prompts Pediatric Oncology Trials

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Related suppliers

Follow us

Products

View more

Webinars