BBK is looking to bring balance to the doctor, patient relationship by improving lines of communication and the productivity of office visits with its online resource, Clinical Notifier.
Sponsors are encouraged to use a master protocol approach to accelerate clinical development programs, though experts say the advantages and challenges should be carefully weighed.
Clinical trial transparency efforts are falling short, with half of trials left unreported, according to a recent UK parliamentary committee report, which calls on the government to take action.
Thermo Fisher opened a new business center and biorepository along with an expanded distribution center, to help support mounting demand for clinical trial supply chain logistics.
Icon reported a record number of new business awards in Q3 and outlined its three-part patient recruitment strategy as well as global hiring – and acquiring – plans.
Compass Pathways’ psilocybin therapy for treatment-resistant depression has received a breakthrough status to accelerate development – at a time when the incidence of mental illness is rapidly increasing.
WuXi Biologics and CANbridge Pharmaceutical have entered into a long-term partnership to develop and commercialize a portfolio of biotherapeutics for rare diseases.
SGS announced it will provide new in vitro toxicology services at its Mississauga, Canada Laboratory following an investment in instruments and laboratory capabilities.
LabCorp sees significant opportunity to grow its Covance Drug Development business in the face of a potentially challenging 2019 and is on track to deliver costs savings as part of its LaunchPad initiatives.
The India-based CRO Veeda Clinical Research has completed a second audit by the Malaysia Regulatory Agency, following 18 US FDA inspections over the past two years.
Iqvia reported a record quarter of contracted bookings during its third quarter earnings call, as the company continues to invest in its technology platform while securing new customers, say CEO.
CROs don’t have sufficient access to clinical research associates (CRAs) to realize market growth, says the CEO of VIARES, which is working to create a new trained and accredited workforce.
BioIVT will use its new internal cloud-based Quality Management System to manage clinical trial data at all of its locations, following the acquisition of five companies since 2017.
Changes at the state and federal level are paving the way for increased participation in clinical trials by providing patient reimbursement for study-related costs.
Certara is using Hedera’s next-generation distributed ledger technology to help the pharmaceutical industry and other stakeholders to ‘capitalize on the myriad of seemingly insignificant activities.’
The American Renal Associates has initiated an investigative site network to bring clinical research to patients while delivering care – and study management services to CROs and sponsors.
An additional investment at the PCI clinical services’ site brought forth an expansion to support the return of investigational drug products used in clinical trials.
New guidances from the FDA update language and provide clarity for innovative approaches to the design and execution of clinical trials, say industry executives.
The FDA is calling on the digital health industry to innovate and proposing a new Center of Excellence for Digital Health – the timing of which is critical, as the industry is receiving more funding and opportunities than ever before, says industry exec.
Oracle is adding goBalto’s clinical trial site selection and activation solutions to the Oracle Health Sciences Cloud – in an aim to deliver ‘the best end-to-end clinical trial experience.’
Zimmer Biomet has tapped Apple and created an app to facilitate patient and treatment team connection as part of a clinical study that aims to enroll as many as 10,000 participants.
Hybrid study designs can be advantageous for the generation of real world evidence, providing a potential solution to the challenges presented by observational studies.
Under the collaboration, Cognate will integrate Terumo’s processing tools into its innovation labs and will serve as a technology reference center for Termo’s devices as well as a beta site for new technologies.
Novotech has acquired a CRO to further support its customers’ clinical research programs across different phases and countries in Asia-Pacific – an area in which it has 10 partnership agreements providing access to more than 1.4bn people.
The online resource organizes and maps myriad sources of research on clinical trial recruitment to help users identify promising interventions, say report authors.
Centogene and Denali entered a strategic collaboration to identify and recruit patients with a gene mutation to be enrolled in a Parkinson’s disease study.
The recent FDA guidance ties penalties for not disclosing clinical trial results to formal inspections – falling short of the public expectation that such data should be readily available, says industry expert.
The companies announced a partnership to integrate 4G’s technology with Clarkston’s clinical supply chain services in an aim to enrich clinical trial strategy and operations.
Metrion has bolstered its drug discovery leadership team, CluePoints has upped its RBM services, and Concept Life Sciences has added to its analytical services division, among other moves this month in the outsourced pharmaceutical services industry.
TriNetX is releasing a series of new tools that will enable more people to conduct health research on their own, with access to rich datasets and analytics, says VP.
Premier Research is expanding its presence in the Asia-Pacific region to include South Korea, Singapore, and Taiwan – with greater health care spending and patient access to new drugs driving demand.
Comprehend, a clinical intelligence software company, has packaged its clinical trial risk detection and management service offerings to accommodate the needs of mid-sized CROs.
The pharmaceutical supply services provider Experic has marked its official launch with plans to construct its headquarters at a newly leased Class A research, manufacturing, and packaging facility.
Specialized capsules and encapsulation techniques can streamline early phase clinical studies – and help researchers meet drug program timelines, says CDMO.
Quanticate is using CluePoints’ software to perform data integrity checks on all types of monitoring and investigator site data as part of its new Data Quality Oversight service.
The identity and access management firm Exostar has acquired UK-headquartered Pirean Limited to provide the pharma industry with simplicity, speed, and security, says VP.
LabKey and Linguamatics have designed an integrated NLP data management solution to help accelerate clinical data abstraction and curation of unstructured notes and reports for clinical research.
Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.
Previous setbacks in Alzheimer’s disease research for disease-modifying treatments have set the stage for a pipeline of new medicines now moving into clinical trials, according to a recent PhRMA report.
After making waves with its launch in June, Javara this week has signed a letter of intent to design an operating model to integrate clinical trials at a medical center in Winston-Salem, NC.
Clinical trials that support FDA approvals of new drugs have a median cost of $19m – representing less than one percent of the average drug development cost, which is estimated at between $2 and $3bn.
