A Full-Service Clinical Research Organization

May 21 2019

Do you BIMO?

James Gaiser, Associate Director, Statistical Programming, PROMETRIKA, LLC.

Quick – What is BIMO?

Is it a flying superhero? Is it an energy drink? Is it the next reality TV show? (Well, it is reality.) Here is a brief overview of BIMO and how it came to be.

Back in 1977, the FDA was granted the right to audit clinical research sites. To meet this new responsibility, the FDA established the Bioresearch Monitoring (BIMO) Program, which created guidelines for agency inspections of clinical trial sites. Gathering site-level data such as details about the investigator, IRB, subject data, and the site itself, to determine which locations to audit, is a time-consuming task for agency reviewers. As you can imagine, this slows the audit planning and completion process, which, ultimately, slows the review and approval of a new treatment. To improve efficiency, the FDA began to look to sponsors for review aids.

Continue reading “Do you BIMO?”
Jan 23 2019

Highlights from the 2018 CDISC US Interchange

Susan Boquist, Associate Director, Statistical Programming, PROMETRIKA, LLC.

The annual CDISC US Interchange brought enthusiasts of standards in clinical trials together in Bethesda, MD in October 2018.  Attendees included programmers, biostatisticians, data managers, managers, regulators, clinicians, and researchers from government agencies, pharmaceutical companies, CROs, universities and medical facilities. The standards specifically governed by CDISC (Clinical Data Interchange Standards Consortium) that were discussed ranged from the protocol through to data collection, tabulation, analysis and beyond.  I was fortunate to be able to attend to hear the latest news and catch-up with old friends and colleagues.

CDISC started out as a purely volunteer organization and, similar to the standards it created, continues to evolve and grow.  This year the new CDISC corporate branding was introduced with much fanfare, and swag was distributed to the attendees.  Along with the bells and whistles comes a renewed focus on the customer (users), the value provided, sustainability of the standards, and optimization of the available tools.  CDISC is heading towards creating standards and tools that allow end-to-end automation of the clinical trial process and data exchange to optimize patient treatment and health. Continue reading “Highlights from the 2018 CDISC US Interchange”

Dec 21 2018

A Wealth of Insight for Biostatisticians at Annual Workshop

Patricia Feeney, Senior Manager, Biostatistics, PROMETRIKA, LLC.

I was very excited to attend the ASA Biopharmaceutical Section Regulatory-Industry Statistics (ASA-FDA) workshop in Washington D.C. in September. It reminded me why I love being a clinical trials statistician and particularly why I enjoy working at a small CRO. The purpose of the ASA-FDA workshop is to provide an opportunity for statisticians and researchers from the FDA, academia, and industry to gather and discuss statistical issues we face in clinical research. The workshop also provides a chance to socialize with fellow statisticians.

The first plenary session discussed ICH E9 R1 – the technical guideline supplementing the E9 document outlining the statistical principles used for clinical trials. It was a great way to set the stage for the remaining two days by reminding statisticians of the importance of design, the choice of the measurements of the treatment effect, consideration of the analysis populations, handling missing data, and the role of sensitivity analyses (see my colleague Benny’s blog about this topic!). Continue reading “A Wealth of Insight for Biostatisticians at Annual Workshop”

Nov 27 2018

ASA-FDA 2018: ICH E9 (R1), Estimands, Intercurrent Events, and Sensitivity Analysis

Benny Chan, Biostatistician III, PROMETIRKA, LLC.

The American Statistical Association (ASA) Biopharmaceutical Section Regulatory-Industry Statistics Workshop (ASA-FDA) is held in Washington D.C. annually. Originally a meeting among only the FDA statisticians, it was later expanded to all statisticians from the industry, academia and the FDA. The result is one of the most relevant conferences for statistical practitioners in the biopharmaceutical industry.

One of the biggest buzzwords at this year’s ASA-FDA conference was “Estimands.”  For those who have not heard the term before, it is defined as follows: Continue reading “ASA-FDA 2018: ICH E9 (R1), Estimands, Intercurrent Events, and Sensitivity Analysis”

Oct 31 2018

American Kidney Fund Pairing for Prevention

Kathy Zheng, MPH, Manager, Project Management and Clinical Innovations, PROMETRIKA, LLC.

PROMETRIKA was honored to be invited back to sponsor the American Kidney Fund’s Pairing for Prevention fundraising event in Cambridge, MA on October 11, 2018. We were glad to see that many of our industry partners who are leaders in the field of kidney research were in attendance as well. Continue reading “American Kidney Fund Pairing for Prevention”

Sep 26 2018

Celebrating 15 Years of Excellence

On Wednesday, September 19, 2018, PROMETRIKA held a reception for our clients and colleagues to celebrate the company’s milestone achievement of 15 years of excellence in business. We are so grateful to everyone who was able to join us for a truly wonderful night! It has been our honor and privilege to serve this industry and contribute to so many life-changing innovations these past fifteen years, and we could not have done that without the trust and collaboration of our clients.

We are so pleased to share with you the video that was presented on that night which details PROMETRIKA’s 15 year journey from small data science start up to top rated, full service CRO.

We hope you have enjoyed hearing our story and we thank you for joining in the celebration. Here’s to another 15 years of collaboration and excellence!

Aug 28 2018

mHealth Strategies for Rare Disease Studies

Kathy Zheng, MPH, Manager, Project Management and Clinical Innovations, PROMETRIKA, LLC.

Companies that specialize in drugs for the treatment of rare diseases face a number of unique challenges during the development lifecycle of their products. One innovation that these companies have turned to is the use of mobile health (mHealth) tools. While the implementation of an mHealth strategy within clinical trials for all indications comes with challenges, the obstacles are even greater in rare diseases. Despite these hurdles, rare disease companies, in their efforts to improve patient experience, have an even greater appetite for technologies like mHealth. Rare disease researchers face increasing pressure from regulatory agencies, investors, and high profile patient advocacy groups to innovate in an effort to expedite the drug development process. The small number of rare disease patients also magnifies the need for an efficient and accurate data collection process. Continue reading “mHealth Strategies for Rare Disease Studies”

Jul 30 2018

FDA Addresses the Challenges of eSource Utilization

Heather Paden, MS, Head, Clinical Operations, PROMETRIKA, LLC

PROMETRIKA Clinical Operations was recently faced with the challenge of initiating the first clinical trial for a specialized research group at a large, academic, world-renowned, oncology research hospital in the US.  The excitement of beginning this phase of product development came with many practical challenges – one of which was how to collate and standardize clinical data collected by many non-integrated electronic health record (EHR) systems.

Until the recent wide-spread adoption of EHR systems, source documentation – all procedures, results and medical assessments recorded for a patient – was provided on paper in physical patient charts.  Today, most of this information is recorded directly into databases by healthcare personnel.  In response, the biopharmaceutical industry envisions the use of EHRs to improve the efficiency and accuracy of data collection in clinical trials.  However, the greatest obstacle to integration of EHRs with the electronic data capture (EDC) systems used in the industry is the lack of standardization among EHR products. Continue reading “FDA Addresses the Challenges of eSource Utilization”

Jun 26 2018

Where Did the Eyeball Go? A Look at RaveX

Dena Hughes, Senior Implementation Specialist, PROMETRIKA, LLC.

PROMETRIKA is pleased to announce that we have successfully implemented RaveX in our Data Management department. RaveX is the latest version of Medidata’s popular Electronic Data Capture (EDC) solution for collecting clinical trial data. Its predecessor, “classic” Rave, has been in use in the industry since 2001.  With our first configuration and release (June 2018) of a clinical trial database utilizing RaveX, PROMETRIKA has navigated the waters of this new Rave user interface (UI) and its Cloud Administration component. In so doing, we have developed a standard set of re-usable processes and procedures around implementation of Cloud Administration, approaches that take advantage of new features and thereby reduce the time and effort required for managing this component of a database using RaveX.

But what, exactly, is RaveX? With classic Rave performing as a tried and true solution, why should you consider switching to RaveX? What benefits would you gain? What pitfalls might you encounter? And who can help you navigate these new waters? Continue reading “Where Did the Eyeball Go? A Look at RaveX”

May 30 2018

Must We Fast Before Lipid Measurements?

Amarachi Umez-Eronini, MPH, Senior Statistical Programmer / Biostatistician II, PROMETRIKA, LLC.

For decades, fasting for 8 to 12 hours prior to blood draw has been the recommended guideline for measurement of lipid profiles.  But does fasting have a clinically significant outcome on the results of lipid level measurement in patients?  Using data provided by the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE-IT-TIMI 22) trial, our group examined this question.

Continue reading “Must We Fast Before Lipid Measurements?”

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