Align Clinical CRO: Leading CROs Form New Industry Standards Group to Improve Collaboration with Sponsors
Six leading contract research organizations (CROs) and Veeva Systems (NYSE:VEEV) today introduced Align Clinical CRO, a new industry standards group dedicated to making it easier for sponsors and CROs to work together during clinical trials. Founding members, with input across the industry, plan to help create open technology standards intended to improve trial execution and collaboration with life sciences companies.
For the first time, leading CROs, including ICON plc, Medpace, Pharmaceutical Product Development, LLC (PPD), PRA Health Sciences, Syneos Health, and UBC are coming together to develop open technology standards to transform clinical trial operations across the entire industry to speed product development.
“There is tremendous potential to enhance clinical trial execution with common technology standards that benefit the entire industry,” said Henry Levy, president of Align Clinical CRO. “The assembly of Align Clinical CRO represents an important industry collaboration to improve the trial process and how the industry works together to accelerate drug development.”
Align Clinical CRO will create open technology standards intended to help increase sponsor and CRO productivity, reduce operational costs, and run trials faster. The group’s first standard is anticipated to be an Operational Data Exchange standard to facilitate seamless information sharing between sponsors and CROs. This is expected to include the definition of a technical standard for data to be exchanged between a sponsor and a CRO relating to the operational execution of a trial, including key metrics and milestone information.
CROs play an integral role in supporting drug development, with clinical outsourcing expected to increase to 50% by 2020.1 As sponsors run a growing number of trials with multiple CROs, developing pre-competitive industry standards will help bring more consistency to trial management and address the complexity of trial oversight to make drug development processes more efficient.
Align Clinical CRO will post its Operational Data Exchange standard for public review and input later this year, which will also be reviewed and considered as part of the adoption of proposed standards. Visit AlignClinicalCRO.org to learn about the group’s mission and stay up-to-date on the standards in development.
What Align Clinical CRO Members Are Saying:
“Leading experts are coming together in Align Clinical CRO to streamline how data is shared between CROs and sponsors during trials,” said Thomas O’Leary, chief information officer at ICON plc. “We look forward to contributing to the group and creating standards that drive greater speed and productivity across the industry.”
“Align Clinical CRO will play an important role in helping the industry accelerate innovation and get new treatments to patients faster,” said Mark Roseman, senior vice president of clinical operations at Medpace. “We are excited to join forces with like-minded CROs that want to move the industry forward and make clinical trial execution more efficient.”
“This is the first time CROs are coming together to make this commitment to transform clinical trials across our industry and we are excited to be part of this effort,” said Michael Brooks, executive vice president of product registration at PRA Health Sciences. “This shows our mutual commitment to make the drug development process more efficient and to help bring needed therapies to market more quickly.”
“Align Clinical CRO will help speed the timeline for gaining new therapy approvals for patients,” said Rachel Stahler, chief information officer at Syneos Health. “By creating a vehicle for CROs to collaborate and share actionable insight with sponsors, we can improve operational delivery and streamline the increasingly complex trial process.”
“UBC is excited to join Align Clinical CRO,” said Brett Huselton, senior vice president of commercial strategy for product and opportunity development at UBC. “We are committed to developing open technology standards that benefit the entire industry and make clinical trial processes more efficient.”
About Align Clinical CRO
Align Clinical CRO is an industry standards group founded by Veeva Systems and the world’s largest CROs, including ICON plc, Medpace, Pharmaceutical Product Development LLC (PPD), PRA Health Sciences, Syneos Health, and UBC. The group is dedicated to creating open technology standards that improve trial execution and collaboration with life sciences companies, making it easier for sponsors and CROs to work together during clinical trials. For more information, visit www.alignclinicalcro.org.
1 CRO Industry Primer: A 2016 Credit Suisse Research Analysis, June 2016
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
XINHUANET: Promotion Event of The Most Beautiful Shooting Location in China Held During Cannes Film Festival25.5.2019 21:20:00 EEST | Tiedote
On May 16 (local time), an event was held at the 72nd Cannes Film Festival to recommend China’s most beautiful shooting locations on the theme of “Fascinating China.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190525005008/en/ The representative from Cannes Convention Bureau (1st L), Michel Chevillon (C), vice president of the French Riviera Chamber of Commerce and Industry and head of hotel association, and Adeline CHAUVEAU (3rd R), officer in charge of film and television projects from French Embassy to China, pose for a group photo with the representatives from the cities awarded for "The most beautiful shooting location in China." (Photo: Business Wire) In the event, the Yellow Sea National Forest Park in Dongtai, Jiangsu Province, the One Hundred Mile Azalea Forest in Bijie, Guizhou Province, Siming District of Xiamen, Fujian Province, and the Li Autonomous County in Lingshui, Hainan Province were on the list. The p
Knopp Biosciences Presents Positive Preclinical Data for Lead Neonatal Epilepsy Drug Candidate at 2019 Antiepileptic Drug and Device Trials XV Conference24.5.2019 17:00:00 EEST | Tiedote
Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases of high unmet need, today presented in vitro and in vivo data for the company’s lead molecule for the targeted treatment of KCNQ2-neonatal epileptic encephalopathy (KCNQ2-NEE) at the Antiepileptic Drug and Device Trials XV Conference in Miami, Florida. KCNQ2-NEE, a rare infant genetic epilepsy, results from mutations in genes encoding the Kv7.2/Kv7.3 ion channel, leading to frequent seizures and profound developmental delay. The preclinical data were presented by Steven Dworetzky, Ph.D., Knopp’s Chief Scientific Officer, a longtime Kv7 researcher who led the group that first cloned the Kv7.2 and Kv7.3 genes during his former tenure with the Bristol-Myers Squibb Co. Dr. Dworetzky presented results demonstrating the in vitro nanomolar activity of KB-3061 and its significant seizure protection in the maximal electroshock mo
Accelerate Your Business in South Korea Through 2019 K-Startup Grand Challenge24.5.2019 13:20:00 EEST | Tiedote
Entrepreneurs from across the globe should set their sights on participating in the 2019 K-Startup Grand Challenge. Supported by the Ministry of SMEs and Startups and National IT Industry Promotion Agency (NIPA) of South Korea, the initiative provides invaluable support and comprehensive resources to early age startups. Applications for the K-Startup Grand Challenge are currently being accepted through June 14, 2019. In order to advance in the program, teams must pass a regional audition. A judging panel of startup ecosystem experts and Korean accelerators will select 40 teams to participate in an enriching 3.5 month-long acceleration program in Korea. The selected teams will have exclusive access to free office space at the Startup Campus in Pangyo Techno Valley, one-on-one mentoring, information sessions, coaching on Korean and Asian business culture and the chance to attend insightful seminars on accounting regulations to tax laws, patents and more. Opportunities for networking with
New Investigational Clinical Data for Ipsen’s Oncology Products in 11 Solid Tumor Types to Be Presented at 2019 ASCO Annual Meeting24.5.2019 08:00:00 EEST | Tiedote
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that new data from clinical studies on investigational uses of cancer medicines cabozantinib (Cabometyx®), liposomal irinotecan (Onivyde®), and lanreotide autogel (Somatuline®, marketed as Somatuline Depot® in the United States) will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting takes place in Chicago, Illinois, U.S., 31 May–4 June 2019; data featuring Ipsen medicines includes: New data from the Phase 3 CELESTIAL trial on the association of adverse events with efficacy outcomes for cabozantinib in patients with advanced hepatocellular carcinoma Overview of the Phase 3 COSMIC-312 trial of cabozantinib in combination with atezolizumab vs sorafenib in patients with advanced hepatocellular carcinoma who have not received previous systemic anticancer therapy First Phase 2 data from the CaboGIST study (trial 1317) from the European Organization for Research and Treatment of
The Posiflex Group Showcases an Ecosystem of Connected Solution Endpoints with IoT Remote Monitoring at Computex 201924.5.2019 04:00:00 EEST | Tiedote
For the Computex 2019 show, The Posiflex Group is featuring leading solution technology from the family of brands as a fully Serviced IoT Ecosystem. Solution end points include: Connected Modular Kiosks, POS Terminals, and Digital Signage solutions from Posiflex and KIOSK Information Systems Smart Medical Displays with gesture controls from Portwell Connected Gaming Solutions with Player Tracking Technology from Portwell subsidiary, Ganlot The booth display is based on common field service endpoints represented in a European Manor Destination Resort setting. Field solutions for an array of vertical market applications include QSR ordering, cinema ticketing, fashion retail customer loyalty, interactive signage, hotel / medical center check-in and bill pay, as well as casino gaming technology. This year, in addition to their renowned POS product suite, Posiflex will be featuring newly introduced Modular Kiosk platforms (co-designed by KIOSK and Posiflex), which are configure-to-order sta
Audi China President Thomas Owsianski to Keynote at CES Asia 201923.5.2019 23:00:00 EEST | Tiedote
The Consumer Technology Association (CTA)TM today announced that Thomas Owsianski, president of Audi China, will deliver a keynote address at the upcoming CES Asia 2019. Now in its fifth year, CES Asia will run June 11-13, 2019 at the Shanghai New International Expo Centre (SNIEC) in Shanghai, China. Thomas Owsianski’s keynote is scheduled for 4 PM, Tuesday, June 11, where he will unveil Audi’s vision in transforming mobility from a driving experience to a digital adventure. Mr. Owsianski joined the top management team of Audi China in August 2018 and was named President in October 2018. “Audi has been at the forefront of driving global transformation in the automotive industry through their breakthrough advancements in technology,” said Karen Chupka, executive vice president, CES. “Innovation has revolutionized the transportation experience, and we welcome Mr. Owsianski to the CES Asia stage to share Audi’s vision for the future of global mobility.” Throughout Asia and beyond, technol
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme