Regulatory affairs

95 Results

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,...

How to Avoid Surprises in Small-Molecule Drug Development Programs

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

Over the years, the pharmaceutical industry has made steady progress in improving the safety of drugs in development. Consequently, in 2015, only 14 percent...

Validating The Simoa Technology

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

Frontage is the first and only laboratory to validate Quanterix’ Simoa HD1 Analyzer for performing immunoassays. Most of the advanced instruments used...

Assessing Pre-Existing Antibodies in Biotheraputic Development

Frontage Laboratories | 21-Aug-2019 | Technical / White Paper

Immunogenicity is the leading reason that biologics fail in clinical trials, and thus it has become imperative for drug development programs to include...