Search Results for: CLINICAL TRIALS Its Time to
QPS Outpaces Market Growth for Phase I Clinical Trials April 23, 2019QPS, a global contract research organization (CRO) providing discovery, preclinical, and clinical drug development services, recently announced its successful implementation...
DRUG DISCOVERY – Zebrafish in Preclinical Drug Development – A Small Fish With Big Returns April 1, 2019
Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.
Saama Closes $40-Million Financing; Driving Disruption in Clinical Analytics & Drug Development March 29, 2019
Saama Technologies, Inc., a leading clinical data analytics platform firm, announced that it has closed a $40 million financing with Perceptive Advisors.
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.
ADC Therapeutics Announces First Patient Dosed in Phase I Clinical Trial February 21, 2019ADC Therapeutics recently announced the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability,...
PPD & HLT to Create Data Science-Driven Clinical Research Solutions February 21, 2019
Pharmaceutical Product Development, LLC and Happy Life Tech of China have signed an exclusive agreement to develop a distinctive service offering for the China drug development market delivering data science-driven clinical trials and real-world evidence of drug products’ effectiveness, safety, and value.
CLINICAL ANALYTICS SOLUTIONS – Reducing Clinical Cost Budget Variations With State-of-the-Art Data Lifecycle Management Solutions January 9, 2019
Srini Anandakumar explores an approach for how sponsor’s operational data, coupled with syndicated data and Real World Evidence data, can enable predictive analytics on clinical cost drivers using a clinical big data and Machine Learning-enabled platform.
CLINICAL TRIALS – Spotlight on Quality in Study Startup: Automated Workflows Encourage Upfront Planning & Downstream Improvements in the eTMF January 8, 2019
Elvin Thalund, MS, and Craig Morgan say the emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall.
Catalent to Open Second Clinical Supply Facility; Enables Broader Integrated Solutions for Global & Local Customers November 15, 2018
Catalent Pharma Solutions recently announced its plans to invest $2.5 million in a new, second clinical supply facility in Shanghai, China, due to open in early 2019. When completed, the facility is expected to employ 100 people and will double Catalent’s total clinical storage capacity in China.
PCI Pharma Services, a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, recently announced the expansion of its Clinical site at Rockford, IL.
CLINICAL TRIALS – How to Make Clinical Trials Patient Centric: Five Common Sense Steps October 1, 2018
Rosamund Round says most companies know they need to make trials more patient-friendly, but few have access to the tools and methodologies to transform their protocol design process. Fortunately, thoughtfully applied common sense practices can create better patient experiences and more robust trials.
Ovid Therapeutics Announces Initiation of Two Phase 2 Clinical Trials September 28, 2018Ovid Therapeutics Inc. recently announced initiations of the Phase 2 ELEKTRA and ARCADE trials for OV935/TAK-935 in pediatric patients with...
PAREXEL Advances Patient-Centric Drug Development With Introduction of its Patient Innovation Center September 11, 2018
PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced the launch of its Patient Innovation Center, designed to help guide sponsors in their efforts to improve efficiency and success across all areas of biopharmaceutical development including clinical trial design, recruitment, execution and market access.
Beta Bionics Receives IDE Approval From the FDA to Begin a Home-Use Clinical Trial Testing the a New Bionic Pancreas System June 6, 2018
Beta Bionics, Inc. recently announced it has received FDA approval to begin recruitment for home-use studies testing the insulin-only configuration of its iLet bionic pancreas system in a series of groundbreaking trials in adults and children with type 1 diabetes (T1D).
Ritter Pharmaceuticals, Inc. recently announced it has signed an agreement with the clinical research organization (CRO) Medpace to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).