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Over the past several years, there has been a rise in nonprofit organizations that focus on addressing the challenges in clinical research.
Over the past several years, there has been a rise in nonprofit organizations that focus on addressing the challenges in clinical research, as the number of new drug development consortia grew from 37 in 1995-2004 to 321 from 2005-2014.10 While many of these organizations are focusing on establishing study site networks, efficiencies and standards, few are starting to dabble into using technologies to link study sites, regulators, and the biopharmaceutical industry / CROs.
Most notably, TransCelerate has announced a collaboration with DrugDev, a study site network technology,9 to bridge the gap between investigators and biopharmaceutical enterprises, and has established a GCP training network to promote training standardization at study sites. Similarly, Alliance for Clinical Research Excellence and Safety (ACRES) has announced the launch of ACRES’ BlueCloudTM, which is a technology interface that promotes the standardization of quality and training, and connects study sites with regulators, IRBs, biopharmaceutical Sponsors and CROs.
In this article, we will comparatively analyze TransCelerate’s and ACRES’ study site standardization initiatives.
Comparative Analysis: TransCelerate | ACRES
Table 1 outlines a comparative analysis between TransCelerate’s and ACRES’ study site training and quality standards initiatives.
Table 1: Comparative Analysis of TransCelerate’s vs ACRES’ Study Site Training and Quality Standards
Table 1 suggests that TransCelerate is focusing on enhancing clinical research operational efficiency and quality with sponsors and CROs. While TransCelerate continues to target its efforts on risk-based monitoring practices and guidances, the nonprofit recently initiated study site qualification and standardization initiatives.8
TransCelerate’s site training and qualification standards resources network includes a listing of GCP training providers that meet TransCelerate’s minimum GCP training criteria.6 Furthermore, TransCelerate has recently formed a collaboration with DrugDev to assist sponsors and CROs with improving the efficiency of locating quality sites during study startup, and is planning on launching the Shared Investigator Platform, which will bring efficiencies towards study site qualification and training. TransCelerate’s focus appears to be tailored towards enhancing clinical trial efficiency, rather than standardization.
TransCelerate was unable to comment at this time.
Table 1 indicates that ACRES is collaborating with a variety of entities including sponsors, CROs, regulators, study sites and service providers to offer a comprehensive solution for enhancing clinical trial safety, quality, and consistency. ACRES is focusing on establishing training consistency and data standards across participating study sites, and is enabling biopharmaceutical sponsors, CROs and regulators to access study site information in a secure technology interface, BlueCloudTM.
The ACRES network is strongly focused on standardization; for example, sites affiliated with ACRES are encouraged to undergo GCP training (and demonstrate documentation of standardized training records), and exhibit the utilization of validated and standardized clinical technology systems (i.e., CTMS, EDC) that meet CDISC standards. Site accreditation information, correspondingly, is shared with stakeholders via BlueCloudTM. Moreover, study sites can integrate their clinical databases into BlueCloudTM to enhance the efficiency of data quality oversight.
“BlueCloudTM is a universal and secure interface for sponsors, CROs, service providers and patient groups to allow them to interact and exchange information,” said Greg Koski, CEO and Founder of ACRES. “It is also a pathway for data flow to enable some of the more sophisticated tools needed for quality management, realtime study site monitoring, and pharmacovigilance,” added Koski. Additionally, Koski indicated that study sites will receive free GCP training as an ACRES affiliate.
Clinical Operations are Standardizing
Through information sharing and technology, clinical trial nonprofit organizations are encouraging the industry to standardize, which is a necessary step to improve operational efficiency, quality, and ultimately facilitate the development, and enhance the safety of new medical therapies.
 FasterCures Consortiapedia via Kenneth Getz, Tufts.