A Different Look at Protocol Procedure Complexity
A substantial increase in procedure complexity should be reflected in increasing per patient costs of Phase III clinical trials,which is not true from this data.
Immunotherapy. It’s Working.
With the initial promise of immunotherapy use in oncology, we need to continue supporting cross-industry collaborations among leaders from the biopharma community, academia, regulators, and private sector investors.
Anti-Clotting Drug Faces Questions Due to Device Issues
An investigation published by the BMJ this week has raised new concerns about the validity of a trial that was used to gain approval for Xarelto from the U.S. and European regulators.
CISCRP's Latest Perceptions & Insights Study
The study gathered responses from more than 12,000 people around the world--including 3,000 study volunteers--about their views and experiences with clinical research.
LabConnect Builds New Biorepository Facility
The facility features space for ambient, refrigerated, cold and ultra-low temperature storage as well as liquid nitrogen vapor phase storage with storage capacity for more than 8 million samples.
LabConnect Builds New Biorepository
ONO PHARMACEUTICAL Selects Medidata
ACRES and GuideStar Clinical Trials Management to Partner
ONO Pharmaceutical Expands Use of Medidata
ONO will be conducting a series of clinical trials in Japan to assess the safety and efficacy of using OPDIVO for a wide range of additional indications, including head and neck cancer.
ACRES, GuideStar Collaborate on Research Site Standards
GuideStar will collaborate with ACRES on its Site Accreditation Standards Initiative as a Strategic Ally.
Radiant Sage Expands Service Offering in Europe
Radiant Sage Expands to Europe
Radiant Sage has partnered with Oslo, Norway-based imaging CRO Clearpoint Image Review Center to provide expanded imaging operations.
Patient-Centric Alzheimer’s Disease Trials
This case study describes how innovative structural design at a study site is leveraging innovative telehealth technologies and nursing home infrastructures to recruit and retain Alzheimer’s patients.
Synexus Announces U.K. Partnership with Firstsource
Because identifying and communicating with patients who are willing to participate in trials can be a significant challenge, Synexus says it is keen to adopt a streamlined process that offers consistency across multiple channels.
Tips to Optimize the Use of eClinical
Paying for the Research Pay-off
Slightly more than a thousand healthcare research projects were funded by the European Union between 2007 and 2013, at a cost of $6 billion, revealed Carlos Moedas, European Commissioner for Research, Science and Innovation, at the end of January.
EMA Adopts New Strategy on Measuring Impact of Pharmacovigilance
New approach focuses on assessing the effectiveness of four key areas related to risk-minimization and pharmacovigilance activities in Europe.
How Do You View the Future of Wearables?
Survey spotlights the concern levels associated with the adoption of clinical trials using wearable technology.
Competitive Pressure for First-in-Class Drugs is Intensifying
Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.
What Google Can Teach Us About Trial Education, Awareness
Search-engine data offers window to public consciousness around clinical trial research, participation.
Preventing Patient Centricity from Becoming a Fad
This three-step process can help managers accurately assess how patient-centric their trials really are.
Clinical Trial Knowledge Missed, Gained, and Shared
Despite wealth of data collected, many inefficiencies exist in the site-sponsor transfer of insights from clinical trials.
Investigator Characteristics & Patient Recruitment in ALLHAT
Analysis of the largest antihypertensive trial ever offers useful blueprint for sites in boosting subject enrollment.
Barriers to Trial Recruitment and Possible Solutions
Survey takes deep dive into enrollment hurdles, aims to inform future recommendations for improvement.
Therapeutic Success or Failure: A Journey, Not Just a Destination
Measuring clinically relevant response requires routine and regular collection of outcomes data.
Applied Clinical Trials, February/March 2016 Issue (PDF)
Click the title above to open the Applied Clinical Trials February/March 2016 issue in an interactive PDF format.
Phase I Death in France: Update
French safety authority confirms what had been speculated--Phase I volunteers received the fifth of the highest dose escalation of the investigational drug at the same time, which goes against EMA recommendations.
Society for Clinical Research Sites Adds Oracle as a New Global Impact Partner
SCRS Adds Oracle as a New Global Impact Partner
Oracle will participate as a Global Impact Partner (GIP) and will participate on the SCRS Global Impact Board at an executive level, and work closely with SCRS’ Leadership Council to determine strategic initiatives for SCRS.
Bioclinica Launches Post-Approval Research Division
Bioclinica has built a post-approval study-specific technology platform along with a Program Coordinating Center (PCC) with dedicated and experienced post-approval research staff.