News

The European Medicines Agency (EMA) has developed a three-year plan to formalize, structure and develop interactions with the academic community.

Schulman IRB announced that research compliance and administration software provider iMedRIS Data is developing the technology to power Schulman’s forthcoming institutional biosafety committee (IBC) service.

A late-March volley of support from the European Union came in the form of a prize awarded to the new European Reference Networks, designed to connect patients with rare diseases to experts across Europe.

Medidata and pharma company Karyopharm Therapeutics announce an expanded partnership.

SCORR Marketing, in collaboration with Applied Clinical Trials, conducted a survey to ascertain the prevailing attitudes toward partnerships between sponsors and outsourcing companies in the health science industry. This report focuses on the type and extent of these collaborations.

The European Forum for Good Clinical Practice to examine the impact of current regulations and areas such as big data and quality management on so-called complex studies.

Application review will require closer cooperation between ethics committees and competent authorities in several areas.

The implementation of the International Organization for Standardization identification of medicinal products (IDMP) is a key step to ensuring that information on new innovations are identified and captured accurately within the regulatory framework and beyond.

Why following one consistent playbook for trial management should be at the core of outsourcing partnerships in drug development.

How to assure that software used in clinical trials will support regulatory scrutiny during pre-approval inspections and application review.

Examining the role of Clinical Research Malaysia in advancing industry-sponsored drug development in the country.

Outlining current regulatory issues and views surrounding expanded access to investigational products in the U.S.

How CROs and sponsors can step up their relationship game.

Click the title above to open the Applied Clinical Trials April/May 2017 issue in an interactive PDF format.

PAREXEL announced the launch of its patient sensor solution for capturing, transmitting, storing and visualizing study subject data in clinical trials.

In Case Report Forms data regarding Concomitant Medication, therapies can be presented in multiple ways. Medical coding is a common task that can ensure the consistency of the captured data.

The last piece in our three-part series on improving efficiencies and sponsor/CRO collaboration through advanced CTMS, reveals a way in which CROs can best their competition in the marketplace.

Stakeholders of Project Data Sphere authored a Sounding Board article in the New England Journal of Medicine urging the responsible sharing of cancer trial data with global researchers.

Medidata announced that The Leukemia & Lymphoma Society has selected Medidata’s Clinical Cloud platform to power its trial for acute myeloid leukemia (AML).

PPD announced the launch of a clinical research associate apprenticeship program.

We previously covered the challenges that biopharmaceutical enterprises are facing when it comes to developing CNS medical products at ExL’s 2nd CNS Clinical Trial Forum. In this interview, Glenn Morrison, Executive Director of Clinical Development at Zogenix, will discuss how biopharmaceutical enterprises can apply techniques used in oncology clinical trials in CNS development.

Oracle Health Sciences released its Data Management Workbench Cloud Service that aims to streamline end-to-end clinical data flows across R&D.