Regulatory affairs

97 Results

Automating clinical trials for success

Formedix | 06-Oct-2021 | Technical / White Paper

This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.

Empowering Clinical Trial Sponsors with Analytics

PerkinElmer | 14-Jul-2021 | Technical / White Paper

Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco...

How clinical trial software can optimize trials

Formedix | 09-Jun-2021 | Technical / White Paper

This article explains the different types of clinical trial software available, and how it can be used to optimize the end to end clinical trials design...

Using SDTM, ADaM, & SEND for Regulatory Submission

Formedix | 16-Nov-2020 | Clinical Study

It’s a safe bet that most people’s first introduction to CDISC is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures...

Covance Touchless Drug and Device Vigilance Vision

Covance Patient Safety | 01-Sep-2020 | Data Sheet

Automation tools enable organizations to identify patterns in structured and unstructured data and facilitate automation of the entire product vigilance...

Global Pediatric Drug Development Collaboration: Part Two

PRA Health Sciences | 09-Jul-2020 | Technical / White Paper

70% of medicines given to children have never been studied in pediatric populations. Children who need treatments represent a relatively small population....

Global Pediatric Drug Development Collaboration: Part One

PRA Health Sciences | 09-Jul-2020 | Technical / White Paper

The pharmaceutical industry is unlike any other industry in that the products manufactured can dramatically improve, and even save, lives. This is especially...

Parents as Gatekeepers for Children with Cancer

PRA Health Sciences | 08-Jun-2020 | Technical / White Paper

The RACE for Children Act will require new drugs intended for adult cancer treatment to also be studied in pediatric cancers when the molecular target...

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Outsourcing Analytical Testing for Biologics - A CRO's Perspective

Frontage Laboratories | 01-Dec-2019 | Technical / White Paper

Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed,...