Featured Editorial
On Rare Disease Day, Are We Making Progress For Patients In Need?
By Ed Miseta, Chief Editor, Clinical Leader

A Q&A discussion around the progress we have made in combatting rare diseases with Douglas Fambrough, president and CEO of Dicerna Pharmaceuticals; Patrick McEnany, president and CEO of Catalyst Pharmaceuticals; and Emil Kakkis, president and CEO of Ultragenyx Pharmaceutical.

Building A Stronger Community For Site-Based Research
By Matthew Roe, M.D., Duke Clinical Research Institute (DCRI); Kaitlin Malone, Amgen; and Gerrit Hamre, Clinical Trials Transformation Initiative (CTTI)

Leading a clinical trial at a research site as an investigator is a challenging task. Running a successful study requires the ability to manage budgets, coordinate the activities of support teams, efficiently allocate limited time and resources, and navigate the complexities of regulations and reporting obligations.

Industry Insights
RTSM Configuration vs. Customization And What It Means For Your Study
Article | By Cedric Druck, 4G Clinical

Know what questions to ask, and what benefits and limitations each approach offers, the next time you are presented with the terms customization and configuration when it comes to RTSM/IRT (or any clinical systems).

6 Steps For Reducing The Risks Of Temperature Excursion
Article | World Courier Management

In clinical trials, the cold chain is far from a secondary concern. When it comes to temperature-sensitive products (tissue samples, cell banks, APIs), any temperature excursion can prove detrimental to the shipment and, ultimately, to the trial. Supply chains are not always predictable or easy to control, and pharma companies need to take a proactive approach to risk management. Sue Lee, technical portfolio manager at World Courier, explains how companies can determine their risks and plan a shipment strategy accordingly.

The EMA Draft Guideline On A GCP Compliant Trial Master File
Article | TransPerfect

The European Medicines Agency recently published a draft guideline titled “Good Clinical Practices (GCP) Compliance in Reaction to Trial Master Files (Paper and/or Electronic) for Content, Management, Archiving, Audit, and Inspection of Clinical Trials.”

Cancer Immunotherapy: Bringing Tomorrow’s Treatments To Patients
Article | Synteract

The immunotherapy field holds great promise. Currently, as an example, these therapies represent a “breakthrough“ in cancer treatment as they have the potential to revolutionize the way we treat many forms of cancer, as well as other diseases and disorders.

Life Science Leader Magazine

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.

Connect With Clinical Leader:
   LinkedIn    Twitter