Welcome to the DATATRAK Blog. Our blog considers the latest in the clinical research industry, offering perspective and maybe a little something to think about.  We cover a wide variety of topics on technology, clinical research, and public health.

dClinical State of Mind

By Marissa Jambrone, DATATRAK Marketing Project Specialist Digital clinical (dClinical) data management solutions are a great option for clinical researchers looking to simplify their study.  What study does not want to speed up the process of getting approved by the FDA? According to a study by the Tufts Center for the Study of Drug Development, “developing a…READ MORE

What’s the Fuss about International Clinical Trials Day?

by Dorothy Radke, DATATRAK Director Marketing Communications Today, May 20 is International Clinical Trials Day. While no one will light a candle on a cake or sing an upbeat song, it’s an important day to just stop and think about clinical research and its effect. Over 268 years ago, a scientist, James Lind, began trials…READ MORE

Social Media Put To Its Best Use – Finally

by Laurence P. Birch, Chairman and CEO, DATATRAK   There is no doubt that social media has created a more connected world.  From sharing photos, videos, and even what you had for lunch, remote friends can share the ‘highlights’ of their friends’ day.  Although that sharing is nice, a higher need is now being filled….READ MORE

C’mon Man!

by Dr. Bill Gluck, Vice President, Clinical Knowledge For those of you familiar with Monday Night football, the segment ‘C’mon Man!’ is one that has some applicability to the pharmaceutical industry.  In the segment, questionable aspects of the game are called into focus, presenting a definitive perspective that calls out the offender with a hearty…READ MORE

Elections and What It Means to Health Care

by Laurence P. Birch, Chairman and CEO, DATATRAK As the power in Washington shifts between parties, the discussion in health care remains the same. How should we, as a nation, address health care, both from the perspective of the physician and the researcher? The Affordable Care Act, often referred to as Obamacare, continues to be…READ MORE

Pay It Forward

by Dr. Bill Gluck, Vice-President, Clinical Knowledge In 2000 a movie entitled ‘Pay it Forward’ was released and it started a social revolution of sorts. Not only has the concept of doing a good deed and asking for nothing in return been popular, it has been a phenomena that has continued for many years. Within…READ MORE

Global Standards in Medical Device, Technology Development

By Dr. Bill Gluck, Vice-President, Clinical Knowledge Recently, the European Forum for GCP (EFGCP) and MedTech Europe established a Medical Technology Working Party to promote the collaboration of defining and establishing standards within the medical device sector of the much larger clinical development industry. As noted by Dr. Klingmann, the Chair of EFGCP, the focus within…READ MORE

Bigger Isn’t Always Better Part II

By Laurence P. Birch, Chairman and CEO, DATATRAK I read a discussion on LinkedIn recently where someone asked for feedback on eClinical solutions to the community of members.  The initial question focused on market share in the industry, by company. There is no doubt that when it comes to market share, the perception is Bigger…READ MORE

Tech Trends Transforming Clinical Trials

from our CEO, Larry Birch Industry after industry, there are many examples of how hyper-connected consumers and social media are changing businesses and forcing entire ecosystems to adapt to the new paradigm. The drug and device development industry is set for dramatic change to realize time and cost savings. Those that are able will lead…READ MORE

From the Desk of Developers & Data Managers

The team that developed the DATATRAK ONE® Unified Experience™ shares their favorite features of the eClinical solutions.  Software Developer, Sean Thrailkill  I helped develop the Unified Experience™ for the Manager tools we use to handle clinical data in the DATATRAK ONE®platform.  I am most excited about how useful the new functionality is. By simply configuring…READ MORE

DATATRAK: Delivering The Unified Experience™ Today

By Niki Kutac, Director, Product Management Over the past decade we have drawn attention to the issues inherent in the frequent practice of merging or integrating eClinical products. However, because major competing vendors almost uniformly utilize an acquisition strategy to expand their product offerings, clients are led to believe that the resulting costs and complications…READ MORE

Mitigating Risk in Clinical Trials: Assessing Technology in Clinical Trials

by Dr. Bill Gluck, DATATRAK Vice President Clinical Knowledge Technology has transformed industries from music to exercise and beyond.  From wearable technology to live traffic flow on your smartphone, the expanding capabilities that are transforming our daily lives are also transforming the clinical trial industry, albeit a bit slower. Today, 70% of clinical trials use eClinical…READ MORE

Mitigating Risk in Clinical Trials: Qualifications and Study Enrollment

by Dr. Bill Gluck, Vice-President Clinical Knowledge The recruitment, or enrollment, of patients for clinical trials is a key factor driving the success or failure of any study. The ability to enroll the correct number of qualified patient/subject populations allows sponsors to optimize logistical issues, including time to identify potential sites, qualify the sites and…READ MORE

Mitigating Risk in Clinical Trials: Subject Safety and Rights

by Dr. Bill Gluck, Vice-President Clinical Knowledge In the development of any drug, biologic, or medical device, it is necessary for some level of testing to be conducted. A series of clinical studies or trials are needed to test and validate the safety and efficacy of the intervention, while ensuring patient safety. In order to…READ MORE

Mitigating Risk in Clinical Trials: The Study Protocol

by Dr. Bill Gluck, DATATRAK Vice President Clinical Knowledge The cornerstone of any clinical trial is the study protocol. As the protocol is the overarching blueprint for the trial, it is imperative to root out risk in this planning stage to optimize the entire trial process. Protocol design impacts both patient and trial risk.  Importantly,…READ MORE

DATATRAK: Delivering the Unified eClinical Experience Today

By Aaron Gadberry, former Director, Software Architecture, DATATRAK Recently, an article was released on the state of eClinical solutions and the need for a unified Experience.  As follow-up to a webinar hosted with their business associates, Medidata published a position paper regarding the issue of eClinical product integration.  Before we begin reviewing the content however, I…READ MORE

Mitigating Risk in Clinical Trials: Introduction & Defining Risk

Dr. Bill Gluck, Vice President, Clinical Knowledge Clinical trials are necessary in the development and testing of pharmaceutical drugs, biologics, and medical devices. From the most common substances found on the drugstore shelf to the most advanced developments in cancer treatments, clinical trials are one piece in the critical path of finding meaningful treatment for…READ MORE

DATATRAK is a Proud Partner in National Health IT Week 2013

September 16-20 2013, DATATRAK, a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, is joining approximately 200 public and private sector organizations to participate in the 8th Annual National Health IT Week (September 16-20, 2013). National Health IT Week 2013 is the premier event offering all healthcare…READ MORE

The 16th Annual Workshop for Clinical Data Management: Smart CDM

At the 16th Annual Workshop for Clinical Data Management: Smart CDM, in Tokyo, Japan, DATATRAK’s Vice President of Clinical and Consulting Services, Dr. Bill Gluck, gave a presentation on The FDA Guidance of Risk-Based Approach to Monitoring as Viewed by CDM. The presentation (located below) discusses the balance of risk and benefit of a risk-based…READ MORE

Top Five eClinical Blogs of 2012

The year of 2012 was a busy year for the FDA. During the year the FDA approved 39 new products and issued many draft guidance documents that have impacted our industry. Below are the top five most popular blogs which address various key FDA guidance documents and other industry-specific topics. 1. Integrating Clinical Operations and…READ MORE

The CDISC 2012 International Interchange and the Need for Standards

The CDISC (Clinical Data Interchange Standards Consortium) 2012 International Interchange “Accelerating Therapies through Standards” was held in Baltimore Maryland on October 22-26, 2012. The meeting attendees had the chance to hear from patient advocates, stakeholders and industry and regulatory leaders about the value of standards for accelerating new therapies for patients, as well as to…READ MORE

Is the Cloud Secure?

What is the cloud? Is it secure? With the idea of the cloud circulating through the life science industry, do people really know what the cloud is and the benefits of using it? Chris Wilke, Chief Technology Officer at DATATRAK, hosted a webinar, Understanding the Cloud. The term ‘cloud-based’ generates a storm of confusion. In fact,…READ MORE

Bigger isn’t Always Better

by Laurnce P. Birch, Chairman and CEO, DATATRAK As recently mentioned in a Wall Street Journal article, Start-Ups Emerge as Tech Vendors of Choice, more businesses are turning to small companies for newer technology and innovative ideas, which is causing a shift away from big tech players such as Oracle. For years, the ‘big players’ have…READ MORE

Second Quarter Highlights

Highlights for the second quarter of 2012 include: Revenues for the second quarter of 2012 increased 10% over the comparable period for 2011 Gross Profit remained stable at 83% Backlog at the end of the quarter totaled approximately $16 million – a 36% increase over backlog at December 31, 2011 and the highest balance in…READ MORE

Best Practices: Centralized Monitoring – Q&A Section

Dr. Bill Gluck (VP, Clinical and Consulting Services) and Lorraine Ellis (President and CEO of Research Dynamics Consulting Group) answered questions asked during last week’s webinar: ‘Best Practices: Centralized Monitoring’. 1. Central monitoring can elimate great % but cannot replace need for site verification. What % can be off-loaded to central or remote site? (LE) –…READ MORE

Congratulations to Durham Technical Community College!

DATATRAK would like to congratulate Durham Technical Community College (DTCC) as they celebrate their 50th Anniversary of service to the community. DATATRAK would also like to congratulate all the students who recently graduated on May 30, 2012 from the Clinical Trials Research program. One year ago (in May 2011) DATATRAK expanded its DATATRAK Academy to…READ MORE

DATATRAK Active in the Life Science Community

Life science organizations are always looking for solutions to help move their research forward safely and swiftly. DATATRAK’s CEO, Larry Birch, gave a presentation on Accelerating Clinical Trials. The presentation given at the Illinois Bio Conference discussed how market challenges create opportunities, technology affects on clinical trial development timelines and the benefits of using a…READ MORE

Ahead of the Curve: Re-engineering and Integration of Clinical Trial processes for Efficiency and Cost-reduction

Guest Blogger: Lorraine Ellis President and CEO of Research Dynamics Consulting Group, LLC. Ahead of the Curve: Re-engineering and Integration of Clinical Trial processes for Efficiency and Cost-reduction Over the past 25 years I have been involved in implementing technology (EDC, CTMS, etc) in Clinical Trials and in revising processes for efficiency and cost-reduction. In…READ MORE

Knowing Your Metrics

Dr. William Gluck VP, Clinical and Consulting Services Metrics are great tools for assessing and evaluating efficiency and effectiveness. They are especially useful when discussing clinical data management and electronic data capture (EDC). Accessing and choosing metrics that have meaning and can be used to assess and evaluate a particular process sometimes poses a challenge….READ MORE

Seven Factors to Consider when Optimizing Clinical Supply Strategies – Q&A

Webinar Overview and Summary of Questions On Tuesday, Chris Wilke, Chief Technology Officer, hosted a webinar working through seven common factors that help to ensure best practices to optimize clinical supply strategies. Wilke named the following as seven key factors that can help determine effective strategies for managing clinical supplies for your study: • Supply…READ MORE