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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 . . .”

Jan 31 2018

Best Friends, Best Practices: The Synergy Between Biostatistics and Medical Writing at PROMETRIKA

Christine Quagan, Senior Medical Writer, PROMETRIKA, LLC

Recent articles in Medical Writing, the Journal of the European Medical Writers Association, recommend collaboration between medical writers and biostatisticians. Authors from one Russian CRO even consider medical writers and biostatisticians to be “best friends forever”!1 This friendship thrives on communication and collaboration.2

With over a decade of collaboration, PROMETRIKA’s medical writers and biostatisticians exemplify the “best friends” described in the articles. An open line of communication is the foundation for the collaboration, enhanced by aligned standard operating procedures (SOPs). The medical writer and biostatistician can then develop a unified approach to meeting industry best practices, including agreeing on templates and style guides, timelines, and level of review required for each draft document. Continue reading “Best Friends, Best Practices: The Synergy Between Biostatistics and Medical Writing at PROMETRIKA”

Dec 29 2017

ePRO Data and Rave: A Match Made in the [Patient] Cloud

Kathy Zheng, MPH, Senior Project Manager, PROMETRIKA, LLC

PROMETRIKA was the first Medidata CRO partner accredited in the Medidata Patient Cloud® platform. As early adopters, we experienced the growing pains of using the Patient Cloud, when we used it as an ePRO solution with Rave. A recent project with a third-party vendor, a leader in the ePRO field, provides a case study for contrasting our experience with the Patient Cloud to that of integrating other ePRO systems with Rave. Continue reading “ePRO Data and Rave: A Match Made in the [Patient] Cloud”

Nov 29 2017

Global Library Data Standards: How They Benefit Cross-Functional Groups at PROMETRIKA

Jennifer Yee, Clinical Data Manager III & Amarachi Umez-Eronini, MPH, Biostatistician I / Statistical Programmer III, PROMETRIKA, LLC

The Data Standards Series: Part 3

As a digital repository for data collection instruments in a Clinical Data Management System (CDMS), a global library (GL) is used to streamline the database build process by increasing quality, time savings, and cost efficiencies.  Although it’s a tool primarily used by Data Management and Database Programming, the GL benefits extend to multiple functional groups within a Clinical Research Organization (CRO).

At PROMETRIKA, some of the groups impacted by the availability of a GL are:

  • Data Management and Database Programming
  • Biostatistics
  • Clinical Operations
  • Pharmacovigilance
  • Project Management

Each of these areas gains unique advantages from the use of our global library.

Continue reading “Global Library Data Standards: How They Benefit Cross-Functional Groups at PROMETRIKA”

Oct 23 2017

CDASH and SDTM: Why We Need Both!

Amarachi Umez-Eronini, MPH, Biostatistician I / Statistical Programmer III, PROMETRIKA, LLC

The Data Standards Series: Part 2

Data Standards Developed by the Clinical Data Interchange Consortium

To streamline the exchange of clinical and nonclinical research data and ensure uniformity across studies submitted to the U.S. Food and Drug Administration (FDA), the Clinical Data Interchange Standards Consortium (CDISC), has developed data exchange standards to streamline clinical research and enable connections to healthcare.  As stated on the CDISC website introduction, “Unlocking cures is our life’s work.  At CDISC, we enable clinical research to work smarter by allowing data to speak the same language.”

Within the CDISC organization, there are several data exchange standards. The most commonly used exchange standards at PROMETRIKA include: Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), and Analysis Data Model (ADaM).  These standards allow sponsors to submit study data in electronic format to the FDA or other regulatory agencies.  As of December 17, 2016, with the exception of CDASH (though strongly recommended), the following data formats, supported by the FDA and listed in the FDA’s Data Standards Catalog, are required when submitting study data. Continue reading “CDASH and SDTM: Why We Need Both!”

Sep 30 2017

The Global Library: The Benefit of Standards in a CRO-Sponsor Partnership

Jennifer Yee, Clinical Data Manager III, PROMETRIKA, LLC

The Data Standards Series: Part 1

The top priority of a Clinical Research Organization (CRO) is to help a sponsor conduct a successful clinical trial. That success is measured in data quality, process efficiency, and cost effectiveness. In order to achieve these goals, many organizations find they benefit from the development of a global library. A global library (GL) is a digital repository in a Clinical Data Management System (CDMS) that contains data collection instruments, such as electronic case report forms (eCRF) and their associated programming elements.

During database build, the library functionality allows for the copying of pre-validated objects, such as variables, code lists and edit checks, from the GL into new projects. Confidence in the pre-validation of the GL allows these objects to be copied without reprogramming or testing. By eliminating these time-consuming tasks, CROs can develop projects with design consistency, significant time savings, and reduced cost; features critical to the success of a study.

Continue reading “The Global Library: The Benefit of Standards in a CRO-Sponsor Partnership”

Aug 09 2017

The Interesting Life and Critical Role of a Clinical Research Associate (CRA)

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

Clinical trials leverage the expertise of people in a wide variety of roles — researchers, project managers, clinical data managers, etc. One of the positions with which people may be less familiar is that of the clinical research associate (CRA). CRAs play a critical, if somewhat unheralded, role in the success of a trial. Continue reading “The Interesting Life and Critical Role of a Clinical Research Associate (CRA)”

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