Data Management & Biostatistics

Clinical Research: Phase 1 - Phase 4

Patient-Reported Outcomes in Fibromyalgia

Fibromyalgia is a chronic, complex pain condition characterized by widespread pain and a diverse range of symptomatic manifestations, including fatigue, sleep disturbance, dyscognition, diminished physical functioning, and mood disturbances. To date, patient-reported outcomes remain the best method for characterizing the many facets of fibromyalgia. Patient-reported outcomes are gaining traction as a highly effective option for...

Clinical Research: Phase 1 - Phase 4

The Placebo Problem, Part 6: Measuring the Placebo Response

This is the next installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. Over the past few weeks, we’ve discussed the psychological, neurobiological, and genetic mechanisms responsible for the placebo response. Today, we turn to the study designs used...

Data Management & Biostatistics

Premier Research Joins TriNetX Global Health Research Network to Access Real-Time Site & Patient Metrics

DURHAM, N.C., JULY 21, 2017 — Premier Research, seeking to accelerate clinical trial design and patient recruitment to better serve its highly innovative customers, has signed an agreement with TriNetX to allow direct query access to its global health research network, comprised of healthcare organizations representing over 84 million patients globally. The Durham-based contract research organization will use TriNetX’s cloud-based platform...

Data Management & Biostatistics

Endpoint Data Capture Strategy: 4 Questions for Sponsors

For a Clinical Endpoint Committee (CEC) to make important decisions, it needs the data to do so. That’s why developing an effective and reliable endpoint data capture strategy is a vital part of working with a CEC. Before starting a clinical trial, sponsors should be able to answer these questions. 1. What needs to be defined?...

Clinical Research: Phase 1 - Phase 4

8 Steps to Jump-Starting a CEC

In our previous CECs blogpost, we reviewed why Clinical Endpoint Committees (CECs) are so crucial for successful trials today. But just how do sponsors establish and operate a CEC? It’s a complex process that can be broken down into these eight key steps: 1. Understand the deep level of commitment required in putting a CEC together....

Data Management & Biostatistics

Premier Insight 244: Data Management: A Growing Challenge, Made Easier

Every day, the world creates and stores 2.5 quintillion bytes of data. If you really must know, that’s 2,500,000,000,000,000,000 bytes. We’re piling it up faster than ever, too — so fast that 90 percent of the data that exists today was created in the past two years. Moving and sharing all that information is a...

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...