Align Clinical CRO’s first technology standard looks to ease data sharing

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/Worawee Meepian)
(Image: Getty/Worawee Meepian)

Related tags: Align Clinical CRO, Veeva Systems, Data, Clinical trials, Icon, Medpace, Syneos Health, Ppd, Pra health sciences

The industry group recently announced its first technology standard, which addresses operational data exchange in an aim to improve information sharing between sponsors and CROs.

Align Clinical CRO is an industry standards group founded last year​ by Veeva Systems and several contract research organizations (CROs), including Icon, Medpace, Syneos Health, PPD, PRA Health Sciences, and UBC.

Henry Levy, president of Align Clinical CRO, said the new standard​ outlines a consistent way for CROs and sponsors to exchange milestone and metrics data, including general trial information, as well as study start-up and patient enrollment information.

It also provides technical considerations when developing APIs for clinical trial systems, according to the organization.

“The standard will allow technology companies to develop simple data exchange solutions to remove the cost and burden of CROs providing custom data exchange capabilities for every trial,”​ Levy told us.

“Ultimately, this can simplify the effort of integrating this data within the sponsor and provider greater oversight into important milestones and metrics throughout a clinical trial,”​ he said.

The standard was developed over several months with input from cross-functional domain experts from eight CROs.

Levy explained, “It was important to the group to develop a standard that was complementary to existing technology standards and be open and free for anyone to use.”

In line with this, the standard is now available for industry review​ and input through March 15, 2019. The final standard is slated to be available in spring of this year.

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


View more