PROMETRIKA, LLC
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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)”

Jul 14 2017

Individual Tumor Profiling: NCI-MATCH Clinical Trial Presents New Treatment Strategy for Patients with Cancer

Perspectives from the Medical Writing Team

Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

“Individual Tumor Profiling:  Has Tumor Molecular Profiling Enabled More Effective and Less Toxic Cancer Treatment?” provides an overview of the use of tumor profiling in the nationwide National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH) clinical trial for treatment of cancer.  This trial is particularly interesting, given the recent US Food and Drug Administration (FDA) approval of KEYTRUDA® (pembrolizumab; Merck), the first approved cancer therapy for solid tumors based on common genetic markers as opposed to initial location of the tumors.   Continue reading “Individual Tumor Profiling: NCI-MATCH Clinical Trial Presents New Treatment Strategy for Patients with Cancer”

Jun 29 2017

Wearable Devices in Clinical Trials: The Current Landscape in Pharma

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

What is mHealth Technology and what are Wearable Devices?

Clinical research is a discipline that is constantly evolving. Currently, the most rapid innovation is occurring in the use of mobile health technology (or mHealth). In particular, wearable devices (also called wearable gadgets or simply wearables) for data-gathering are becoming a major focus for many pharmaceutical companies.

The integration of wearables with smartphones has made the collection of a continuous stream of real-time data less disruptive for participants. This emerging digital research platform holds the potential for increasing the accuracy and timeliness of data, improving clinical efficiencies, and promoting greater patient engagement in the clinical trial process. Continue reading “Wearable Devices in Clinical Trials: The Current Landscape in Pharma”

May 25 2017

Ocrelizumab: The Long Road to Approval

Perspectives from the Medical Writing Team

Tahmeena Chowdhury, PhD, Medical Writer, PROMETRIKA, LLC

In “After 40-year odyssey, first drug for aggressive MS wins FDA Approval,” (Stat News, March 28, 2017), Ron Winslow describes the fascinating journey of Roche’s new multiple sclerosis (MS) drug to obtain US Food and Drug Administration (FDA) approval.  This drug, ocrelizumab, offers new hope to the 10% to 15% of MS patients who have primary-progressive disease (PPMS).  The approval of ocrelizumab not only provides a promising therapeutic option to patients with MS, but also represents a textbook example of the importance of innovative thinking and perseverance in scientific research; the latter being one of the main reasons I elected to write about this article.

Continue reading “Ocrelizumab: The Long Road to Approval”

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