Updated employee announcements, business awards and recognition, and company news.
People
The Clinical Data Interchange Standards Consortium (CDISC) has named Dr. Lauren Becnel as Senior Director of Biomedical Informatics and Alliances. Dr. Becnel will focus on informatics technologies, especially the CDISC metadata repository, Shared Health and Research Electronic Library (SHARE), which houses all of the CDISC standards and ensure that CDISC research standards are relevant not only for regulated research but also for academic research centers and precision medicine.
Dr. Lauren Becnel
DIA announced that Jonathan Commons has been named senior vice president of marketing. He will lead the global marketing and business development teams for DIA. He most recently served in global roles as the Senior Director of Digital and Patient Engagement at Chimerix and Vice President of Investigator Education and Patient Engagement at Quintiles.
CTI Clinical Trial and Consulting Services has hired the following new employees:
Adam Brown as Research Associate; Jennifer Burge, Regulatory Specialist; Brianna Earle joins as Safety Scientist II; Dan Minham an IT Validation Analyst; Afua Premoh as IT Support Specialist; John Redden joins as Research Associate and Katherine Thompson, Clinical Research Coordinator.
From left to right: Jeni White, Michael Romes, Meredith Dees, and Kate VanGilder.
From left to right: Chris Kaas, Jeff Osterhaus, Michaela Heekin and Molly McKean
The company also announced the following promotions: Jeff Barbian promoted to Study Coordinator; Meredith Dees to Assistant Manager, Clinical Systems Operations; Kate Van Gilder to In-House Clinical Research Associate; Kristen Harding and Bret Marshall as Study Coordinators; Michaela Heekin to Human Resource Coordinator; Chris Kaas to Assistant Director, Information Technology; Molly McKean to Project Manager; Jeff Osterhaus promoted to Senior Manager, Business Development Operations; Michael Romes to Assistant Manager, Research Associates; and Jeni White to Clinical Operations Coordinator.
Medidata has named Christian Hebenstreit its managing director of EMEA (Europe, the Middle East and Africa). Hebenstreit will be based at Medidata’s EMEA headquarters in London and head operational functions in the region.
Christian Hebenstreit
Central Logic, a provider of transfer center and on-call scheduling technology healthcare solutions, has hired James Moore as its Senior Data Scientist. Moore has received multiple awards for his work including a data mining project that used logistic regression to find Medicare billing errors. He most recently was Director of Service Analytics with Progrexion Marketing in North Salt Lake, UT.
CROMSOURCE has appointed four senior executives to its Management Team. They include: Dr. Troy W. McCall as Chief Operating Officer (COO), Debbie Kent as Global Head of TalentSource staffing solutions, Dr. Kerry Dyson as Global Head of Clinical Research Division and April McCall as Vice President of Commercial Operations.
Business News
Worldwide Clinical Trials has opened a new, larger 1,300 square meters depot site in St. Petersburg, Russia. It allows for the storage and distribution of a wide range of clinical trial materials with special requirements and conditions for storage, as well as distribution.
PPD has expanded its medical communications services into the Asia-Pacific region, and will be managed by teams in Tokyo and Singapore. These operations join the existing services in North America, Latin America and Europe.
CROMSOURCE announced the expansion of its North American presence with the opening of an office in Research Triangle Park in North Carolina.
Recognition
Quintiles has been named to the 2016 CSO50 by IDG's CSO Magazine, and is in recognition of its Identity Management Solution, which introduced identity vetting, identity storage and identity synchronization to improve data quality for both existing and newly established users.
ProTrials Research is celebrating 20 years of clinical research excellence. Launched in 1996 by industry veterans Jodi Andrews and Inger Arum. To commemorate their anniversary, the company is launching Twenty for Twenty: ProTrials Celebrates Two Decades of Clinical Research Excellence. The storytelling initiative will profile a company milestone that occurred each year over the last 20 years on the company's LinkedIn and Facebook pages.
PPD has been named, for the fifth time, to the InformationWeek Elite 100, a list of the top business technology innovators in the United States. PPD’s technology features wearable or mHealth technology, and Preclarus®, its portfolio of solutions for clinical trial operations.
LabCorp announced that Covance Drug Development has received the Clinical & Research Excellence (CARE) Award for Best Sponsor-Focused Technological Development for its Xcellerate® Monitoring solution, central monitoring.
Certara®, a global biosimulation technology-enabled drug development company, announced that Adam Darwich, PhD, has been appointed Certara Lecturer in Precision Dosing at the Manchester Pharmacy School at The University of Manchester in England. Certara has endowed this to advance teaching and research of modeling and simulation for individual dose optimization.
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.