Introducing Applied Clinical Trials’ new enewsletter, CRO News, which provides a forum for the industry to discuss the latest alliances, financial information, and business deals and developments, as well as people news.
Premier Research Group and Octagon Research Solutions
Premier Research Group, a Philadelphia-based CRO, and Octagon Research Solutions a electronic solutions provider based in Wayne, PA, announced in late April the companies' formal intent to combine Octagon's electronic submissions capability with Premier's expertise across therapeutic areas. Each company will partner to offer the other's capabilities to its respective clients.
>> MORE
Clinsys Freshens Up Its Services
Within the span of two days, Clinsys Clinical Research announced two strategic moves. The Bedminster, NJ-based, therapeutically-focused CRO introduced its Therapeutically-aligned Program Strategists. These teams consist of MDs, PhDs, and a clinical operations program director with expertise in a specific therapeutic area. Its second announcement was the launch of Clinsys ALTERNA, billed on its Web site as providing customized Phase I through IV clinical trial alternative solutions.
>> MORE (TPS) >> MORE (ALTERNA)
CRO Goes Green
At ProTrials, the environment is an important issue, and one that employees support. Read more about how the Mountain View, CA-based CRO initiates green policies in this interview with co-founder and president Inger Arum.
>> MORE
Axiom Accelerated Patient Recruitment
Partner with Axiom Accelerated Patient Recruitment to develop customized recruitment initiatives that motivate qualified patients. Leave Patient Recruitment To The Experts. Visit:
PERI's Global Regulatory Affairs: Overview of Drugs & Biologics
May 19–21, 2008
Location | Washington, DC
SMi's Clinical Trials Logistics
May 21–22 , 2008
Location | London, UK
DIA's 2nd Annual Conference for Asian New Drug Development
May 29–30 , 2008
Location | Tokyo, Japan
"A Quick Guide to Clinical Trials" was recently unveiled. The book was edited by Dr. Madhu Davies and Dr. Faiz Kermani. Click here for a review of the book.
Check out the CRO + EDC Special Report from ClinPage for insights into this group dynamic. Part III is here.
We're looking forward to the outcomes from the Post-Approval Summit being held at Harvard Medical School today and tomorrow. Link here to read the high-powered agenda at the Summit's site.
Increasingly complex protocol design is negatively impacting clinical trials, and a new study confirms it. Read Ken Getz's column about it here.
ClinPhone and invivodata announced a global ePRO partnership. Click here to read more.
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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.
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.
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