Data Management & Biostatistics

Data Management & Biostatistics

Premier Insight 245: Getting Creative: A Hybrid Answer When the Conventional Won’t Do

When the going gets tough, the tough get … creative. The search for the best resourcing solution sometimes defies a single answer. That’s when Premier Research combines outsourcing, insourcing, and geographic flexibility to devise a hybrid solution. Rethinking data operations A small oncology-focused biotech company presented such a challenge when seeking to contract out its...

Data Management & Biostatistics

Premier Insight 247: Forty Percent Savings in Four Weeks: Yeah, We’re That Good

A U.S. pharmaceutical company needed an immediate outsourcing solution to replace an underperforming vendor. Not only was time critical, cost was, too. These new data specialists would be located offshore to reduce the sponsor’s overhead. Oh, and did we mention it had to be done fast? Higher performance, lower cost Premier Research stepped in and...

Data Management & Biostatistics

Coding Expert Joins B3/C3 Format Discussion at WHODrug Meeting

DURHAM, N.C., June 23, 2017 — A Premier Research medical coding expert will take part in a panel discussion on the new WHODrug B3 and C3 formats. Lubomir Tarabcak, Manager of Medical Coding, will be taking part in the hour-long panel at the WHODrug User Group Meeting, June 23 in Chicago. The discussion, to begin...

Data Management & Biostatistics

Quality Expert to Discuss Data Integrity at DIA Annual Meeting

DURHAM, N.C., June 19, 2017 — Data integrity has been a prime focus of pharmaceutical regulators for two decades now, but the focus is sharpening markedly with issuance of new guidance from multiple regulatory authorities. Sherri Hubby, who leads quality assurance, risk, and compliance at Premier Research, will address this trend and its implications at...

Consulting

4 Obstacles to Collecting Quality Data in Psychiatric Drug Trials

Sponsors often face significant challenges in collecting robust, quality data that demonstrates the safety and efficacy of investigative psychiatric drugs. However, before these problems can be solved, they must be understood. Be sure to keep these four issues in mind when mapping out strategies for ensuring quality data collection in psychiatric clinical trials. 1. There...

Clinical Research: Phase 1 - Phase 4

Wearable Wrist Sensors Enable Detection of Stress, Seizures, and Pain

Wearable medical devices are yielding increasingly important insights into health. Rosalind Picard, Sc.D., professor of Media Arts and Sciences at MIT, discussed the applications of one such device, wearable wrist sensors that measure electrical changes in the skin, in an informative plenary lecture we attended at the American Pain Society’s 36th annual meeting in Pittsburgh,...

Clinical Research: Phase 1 - Phase 4

Premier Insight 250: A Study That Wasn’t Working Until Premier Research Stepped In

A customer called on us to rescue a study that just wasn’t going well. (It happens a lot.) The challenge was to deliver data the company needed to make a go-/no-go decision at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat...

Clinical Research: Phase 1 - Phase 4

Premier Research Launches Electronic Collection of Clinical Trial Patient Data

  DURHAM, N.C., MARCH 24, 2017 — Premier Research is launching a smartphone-based patient reported outcome system to replace the paper diaries used in many clinical trials. Premier Mobile ePRO will give sponsors and researchers more accurate and timely patient reported data while reducing the burden on trial participants. “Any study is only as good...

Data Management & Biostatistics

Strategies for Collecting Quality Data in Psychiatric Clinical Trials

We’ve gathered questions from our customers and vendors regarding potential impact of COVID-19 on current and planned studies. Find resources to help ensure trial continuity here: https://premier-research.com/top-considerations-covid-19/ Sponsors of psychiatric clinical trials may face significant challenges in collecting robust, quality data to support the efficacy and safety of investigative compounds. Identifying and mitigating study design-,...

Clinical Research: Phase 1 - Phase 4

Want to Study Rare Disease? Get Ready for These Roadblocks

A rare disease, also referred to as an orphan disease, by definition affects a small percentage of the population. Most are genetic and appear early in life, with one in three children with a rare disease dying before their fifth birthday. While the definition of “rare” varies from country to country, the US defines a rare disease as...