Celebrating Fifteen Years of Excellence Celebrating Fifteen Years of Excellence

A Full-Service Clinical Research Organization

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?”

Apr 20 2018

Keys to Success in Medical Coding With Medidata Coder®

Cathy Hult, Director, Data Management, PROMETRIKA, LLC

Coder is a Medidata application designed for mapping verbatim terms (e.g., adverse events [AE], concomitant medications [CM], and medical history [MH]) to specific terms in industry standard dictionaries (i.e., MedDRA, WHODrug).  Coder is integrated with the Medidata Rave EDC system, allowing terms entered in Rave EDC to be directly transmitted into the Coder application for processing, and then transmitted back into Rave once coding is complete.

PROMETRIKA, LLC was accredited in the Coder platform in March 2017.  In the short time we have been using it, the flexible Medidata coder platform has already proven efficient in assigning codes to verbatim terms in real time when integrated with Rave studies.  Continue reading “Keys to Success in Medical Coding With Medidata Coder®”

Mar 26 2018

SDV – What is it good for? Absolutely nothing?

Stephen Cropper, Senior Clinical Research Associate, Clinical Operations, PROMETRIKA, LLC

In recent years, much has been said about Source Document Verification (SDV), the comparison of information reported by an investigator to original source records to confirm its completeness, accuracy, and validity. The term SDV seems to mean different things to a lot of people. Some suggest that SDV is only the simplest form of transcription checking, with a goal of simply ensuring that the eCRF matches the patient’s medical records.

The accepted norm for assuring clinical trial quality had been 100% SDV, but there is no evidence that suggests it improves overall data quality, and FDA & ICH regulations do not require it. A process that includes 100% SDV review can be very time-consuming and expensive. Has the time come to change how we approach SDV in clinical research? Continue reading “SDV – What is it good for? Absolutely nothing?”

Feb 28 2018

The Best Way to Develop Regulatory Submission Documents? Survey Says . . .

Christine Quagan, Senior Medical Writer, PROMETRIKA, LLC

Recently, the Medical Writing Team at PROMETRIKA completed our second New Drug Application (NDA) submission within a year.  The process of developing the suite of documents for each submission – including the integrated summaries (ISS and ISE), clinical summaries (SCS and SCE), and clinical overviews (COS and COE) of safety and efficacy – involved much collaboration among the writers, biostatisticians, and the sponsors’ clinical development teams.  Without it, the team would not have been able to meet the tight submission timelines set by the sponsors.

With our experience fresh in our minds, we read the article “A Pilot Survey of Strategies for the Development of Clinical Summary Documents” in a recent issue of the American Medical Writers Association Journal.  How similar was our experience to other writers who developed submission documents? Continue reading “The Best Way to Develop Regulatory Submission Documents? Survey Says . . .”

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