CTTI has completed more than 25 projects on issues affecting clinical trials over the past decade, since which time the industry has changed greatly, says executive director.
IAOCR and PCMG have released a new set of standards to establish a consistent approach to managing clinical outsourcing to ensure clinical trials have a better chance of running optimally, says co-founder.
The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.
Advarra has selected TransPerfect Life Sciences as its strategic supplier of language services, including document translation, digital content localization, and interpretation services.
SIRO Clinpharm is in “a new area of growth” following the procurement of ArisGlobal’s LifeSphere Clinical platform, which has enabled the company to expand its business prospects, says CRO.
The number of new clinical trials in the regenerative market space continues to grow, says Cryport, which will provide global logistics support for TiGenix’s upcoming Phase Ib/IIa study.
Medidata and Syapse have teamed up to develop a new suite of solutions, which will aim address precision medicine challenges and accelerate clinical research in oncology for trial sponsors.
An update to guidance on patient payments in clinical trials has been released by the US FDA, urging institutional review boards and investigators be wary of undue influence impacting subject consent.
Biomedical and pharmaceutical stakeholders have heralded the news that Chinese researchers have successfully cloned a monkey and its potential to unlock further our understanding of complex diseases.
CTI Clinical Trial and Consulting Services (CTI) has opened a new office in Singapore – a location that will enable the CRO to attract and retain talent as it continues expansion in Asia.
Weill Cornell Medicine has joined TriNetX’s global health research network, enabling it to collaborate with researchers and attract clinical trial opportunities.
Alligator Bioscience says an existing agreement with Theradex informed its decision to re-sign the CRO, this time to test metastatic cancer candidate ATOR-1015.
Apple has updated its Health app to give users access to their medical records – a new feature that could fundamentally change the way research is conducted, says Medidata.
Concept Life Sciences has teamed up with the UK-based bioanalytical contract research organization (CRO) Alderley Analytical to provide customers with bioanalytical and DMPK study services.
SQN Clinical has launched SQN Health, a mobile electronic Patient Reported Outcomes (ePRO) and Clinical Outcome Assessment (eCOA) application, which provides real-time and ongoing patient and data oversight.
The US Food and Drug Administration (FDA) is launching a new pilot program this month aimed at increasing clinical trial transparency – though many opportunities remain to improve the scope, clarity, and usability of data, says TrialScope CSO.
Japan’s proximity to China, pharmaceutical infrastructure, and workforce capabilities helped inform Biorasi’s decision to launch regional headquarters in Tokyo, says executive.
Revisions to the Federal Policy for the Protection of Human Subjects has been delayed six months, possibly more, as regulators cite the rule’s complexity, lack of guidance, and other challenges.
Celerion has integrated its proprietary electronic data acquisition system, ClinQuick, with OmniComm’s electronic data capture (EDC) solution, TrialMaster, to create a fully automated clinical trial data management platform.
PPD and Quotient Sciences have announced a new collaboration to accelerate pediatric drug development – as developing age-appropriate medicinal formulations will continue to be a focus of regulators, clinicians, and parents, says PPD senior VP.
PRA Health Sciences has opened a new clinic in Salt Lake City, which will offer full-service early stage clinical research capabilities for healthy participants and specialized patient populations.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) recently established a new advisory council devoted to patient engagement.
Exclusion of brain metastasis patients from clinical trials of anti-cancer drugs could remove up to two-thirds of the stage IV population, say researchers who have published new guidelines aimed at bringing attention to opportunities for improvement.
Massachusetts biopharma companies received $2.9bn in venture capital investment in 2016 – and as pressure continues to accelerate the drug development process, manufacturers will continue to turn to CROs and CMOs, says MassBio.
Optimapharm has acquired MKS Research as it plans to double its revenue and become the largest independent contract research organization (CRO) in the Central and Eastern Europe (CEE) and South East Europe (SEE) regions.
LabCorp’s Covance has launched a new dedicated offering for biotech, medical device, and diagnostic companies following its purchase of Chiltern in 2017.
DNAnexus has secured $58m financing, including a strategic investment from Microsoft, in order to further develop its translational medicine solutions.
A proposed Final Rule, which would delay the implementation of the revised Common Rule, comes as a surprise to many in the institutional review board (IRB) community, says WCG compliance VP.
Sekisui XenoTech hired in record numbers in 2017 as it anticipates 10% or higher growth over the next couple of years fueled by demand for drug-drug interaction studies.
INC Research/inVentiv Health is starting the new year with a rebrand after merging to create one of the largest biopharmaceutical outsourcing providers in 2017.
The Patient Engagement Collaborative will include 16 patients, caregivers, and patient group representatives who will provide “a collective, all-encompassing patient voice,” says CTTI project manager.
Outsourcing models examined, market shifts scrutinized, and trial tribulations analyzed – take a look back at some of the top reports published in 2017.
The Good Pharma Scorecard aims to quantify what makes a “good” pharmaceutical company – as 91% of Americans think companies put money before people, says Bioethics International founder.
In 2018, the industry can expect risk-based everything, cloud-first strategies, and a focus on modernization as companies look to stand out amongst the competition, say Veeva Systems execs.
Parexel has enhanced its clinical data service offering with the addition of new features to further support data collection and analysis as well as adaptive trial design.
The National Institutes of Health (NIH) has created a new clinical trials consortium with a model focused on streamlining research and diverse recruitment.
TriNetX has announced the general availability of its natural language processing (NLP) service, which uses sophisticated algorithms to extract data from physician notes and clinical reports, says CTO.
