PROMETRIKA, LLC

A Full-Service Clinical Research Organization

PROMETRIKA to coordinate Phase I trial for MD Anderson’s Institute for Applied Cancer Science

Cambridge, MA-based clinical research organization to manage Phase 1 acute myeloid leukemia study

CAMBRIDGE, MA, March 20, 2017 - PROMETRIKA, a boutique full service clinical research organization, is coordinating a Phase 1 trial for The University of Texas MD Anderson Cancer Center's Institute for Applied Cancer Science. PROMETRIKA is responsible for the clinical trial management and site monitoring, medical monitoring, database implementation and data management, study drug management, pharmacovigilance, biostatistics, and medical writing. This trial is in acute myeloid leukemia (AML), which is a rare form of cancer with approximately 10,500 new cases each year in the United States.

"We are thrilled to work on this important trial alongside the institution in its pursuit to end cancer", said Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA.

As a CRO focused on both rare diseases and oncology, this study presents another opportunity for PROMETRIKA to leverage its considerable expertise and experience in AML in the ongoing fight against this devastating disease.

About PROMETRIKA, LLC - www.prometrika.com
Founded in 2003 and based in Cambridge, Massachusetts, PROMETRIKA is a unique Clinical Research Organization (CRO), utilizing a collaborative approach to clinical development and execution with a close-knit, highly-experienced senior leadership team involved in all phases of trials. PROMETRIKA’s services include complete clinical operations and clinical trial management, data management, pharmacovigilance, biostatistics and programming, medical writing, and regulatory submissions.

 

PROMETRIKA Growth Across All Areas Leads to Office Move

PROMETRIKA moves to a new office in Cambridge, MA with 60% more space.

CAMBRIDGE, MA, October 14, 2016 -- - PROMETRIKA (www.prometrika.com), a full-service Clinical Research Organization (CRO), has moved to a larger space in Cambridge, MA. The move is driven by PROMETRIKA’s recent growth that has been in response to an increase in demand from their pharmaceutical, biotechnology and medical device clients for full-service clinical research offerings.

“PROMETRIKA has experienced tremendous growth over the past several years, thanks in large part to the faith our clients have had in our work. In the past two years, we have added 25 new members to our PROMETRIKA team,” said Vahe Zeroonian, Principal & CFO of PROMETRIKA. “We have had remarkable expansion among our clinical operations team and services, and we have continued to grow our strong biostatistics and data management staff at the same time. This growth has required us to move to a space that will accommodate our continuously-expanding team.”

PROMETRIKA has moved its offices to a new location at 100 CambridgePark Drive in Cambridge, Massachusetts, giving them 60% more office space. The office is located across from the Alewife T station, just four stops from Kendall Square.

“It has been a remarkable journey since I started PROMETRIKA in 2003, and the last few years have been particularly exciting,” stated Miganush Stepanians, Ph.D., President and CEO of PROMETRIKA. “Today our partnerships with our clients are often broader, more strategic, comprehensive and long-term, covering the span of product development from phase 1 through regulatory submissions. It is this shift in how we are partnering with our clients that is driving our growth; we need to ensure we have the capacity and space to continue to collaborate as a team and exceed our clients’ expectations.

 

PROMETRIKA’s President and CEO, Miganush Stepanians, PhD will moderate July Edition of MassBio’s Digital Healthcare Series

“Mobilizing” Clinical Trials: New Technologies for Accuracy, Efficiency and Real-Time Data Capture

When: July 21st, 8AM–10AM

Where: MassBio Offices: 300 Technology Square, 8th Floor, Cambridge, MA 02139

Digital Health: Summer Forum Series CAMBRIDGE, MA, July 18, 2016 -- This week, the second Forum of a three-part series on the challenges and opportunities of digital healthcare will take place at MassBio’s headquarters in Cambridge, MA. This event will feature a panel of industry leaders, and will be moderated by PROMETRIKA’s own Miganush Stepanians, Ph.D., President and CEO.

We are excited to be part of this great discussion on uncovering what digital healthcare means for life sciences industry professionals and how it affects patients. This forum will highlight how digital health technologies -- such as wearable devices, mobile applications, sensors and more -- have the potential to revolutionize clinical trials and natural history studies.

We hope you will join us to learn how these technologies can support real-time trial oversight and accurate, efficient and timely data capture from the following panelists:

  • David Alexanderian, DO, Medical Director, Global Clinical Development Lead, Shire Pharmaceuticals
  • Amit Rakhit, MD, MBA, Chief Medical and Portfolio Management Officer, Ovid Therapeutics
  • Ahmet Uluer, DO, Director, Adult Cystic Fibrosis Program, Boston Children’s Hospital; Director, Weitzman Family Bridges Adult Transition Program; Assistant Professor of Pediatrics, Harvard Medical School
  • Kathy Zheng, MPH, Sr. Project Manager, PROMETRIKA, LLC

To register for this event or find more information, please click the link below. This event is free for members, and open to nonmembers for a $35 fee. Members also have the option to live-stream this forum if they are unable to attend in person.

https://www.massbio.org/events/mobilizing-clinical-trials-new-technologies-for-accuracy-efficiency-and-real-time-data-capture-1424

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PROMETRIKA Delivering Two Presentations at the Upcoming 2015 Medidata Symposium

CAMBRIDGE, MA, September 28, 2015 -- PROMETRIKA, LLC, a full-service clinical research organization (CRO), has been selected to deliver two presentations at the 2015 Medidata Symposium being held from October 5th-7th in Washington, DC. Kathy Zheng, Project Manager, will be delivering both talks. The first, entitled “Patient Cloud®: Implementation Challenges and Other Lessons from Beyond Go-Live”, will be on Tuesday October 6th at 3:30 PM and the second, entitled “Drafting an RTSM Team and Training for Go-Live” will be on Wednesday October 7th at 11:45 AM.

PROMETRIKA’s CEO and President, Dr. Miganush Stepanians noted, “Kathy has been a key participant in the implementation of both Balance and Patient Cloud at PROMETRIKA. I am happy that she has been selected to share the knowledge she has gained with the broader Medidata user community”.

PROMETRIKA has been a partner of Medidata since 2011 and has developed processes associated with the Medidata platform to effectively deliver the highest quality data management services.

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Full-Service CRO PROMETRIKA Expands Use of Medidata’s Cloud-Based Platform to Drive Cutting-Edge Clinical Development: Increased Adoption of Medidata’s Patient-Centric Data Capture and Management Solution Enables Significant Operational Efficiencies and New Productivity Across PROMETRIKA’s Clinical Trials

Click here to see the full press release

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PROMETRIKA Announces the Availability of Pharmacovigilance Services

CAMBRIDGE, MA, June 2, 2015 -- PROMETRIKA, LLC, a full-service clinical research organization (CRO) has expanded its offerings with the addition of pharmacovigilance services for clinical trials. PROMETRIKA has selected ARISg™, a world leader in safety data collection and reporting, as our service platform. Our drug safety and regulatory affairs professionals, and expert physicians, each with more than 23 years in the biopharmaceutical industry, provide clinical interpretation and monitoring of safety trends.

PROMETRIKA’s CEO and President, Dr. Miganush Stepanians noted, “In response to our Sponsors’ increasing needs for accurate and dependable safety monitoring and reporting, we now offer trial safety monitoring with the worldwide reporting capabilities crucial in today’s drug development environment.”

Pharmacovigilance services for all phases of clinical trials can be provided as a stand-alone service or in conjunction with clinical operations, monitoring, data management, biostatistics, and medical writing services offered by PROMETRIKA.

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Join the Boston Chapter of the American Statistical Association & Boston University Biostatistics for a Short Course on Patient-Reported Outcomes: Measurement, Implementation and Interpretation. PROMETRIKA’s Dr. Jim MacDougall, President of the Boston Chapter – ASA, hopes to meet you there.

See the attached PDF with more details on the class.

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PROMETRIKA proudly congratulates our own Dr. Miganush Stepanians, President and CEO, on her selection as co-chair of the Biostatistics-Data Management-Clinical Trials (BSDMCT) working group of the Massachusetts Biotechnology Council (MassBio)

Dr. Maganush Stepanians Dr. Stepanians, a biostatistician and founder of PROMETRIKA, has been selected to co-chair the BSDMCT Working Group of MassBio. In her two-year tenure as co-chair, Dr. Stepanians and her colleagues will develop industry-relevant programs and bring subject matter experts to MassBio’s forums covering the industry’s most timely topics.

Dr. Stepanians holds an MS in Mathematics (Statistics) from MIT and a PhD in Statistics from BU. In her 30 year career, Dr. Stepanians has been active in clinical trial design, data management systems development, and statistical analysis of clinical trial data. She has managed the statistical analyses of many NDA filings in varying indications and regularly represents sponsors at FDA meetings. In addition to her current responsibilities as PROMETRIKA’s President and CEO, Dr. Stepanians is actively involved in project work for PROMETRIKA’s clients. She provides trial design and statistical analysis consulting and sits on Independent Data Monitoring Boards (IDMBs). Prior to founding PROMETRIKA, Dr. Stepanians was Director of Biostatistics and Data Management at Muro Pharmaceuticals.

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PROMETRIKA-Boston University Partnership Helps Mentor New Talent for the Pharmaceutical Industry

Boston University Partnership Helps Mentor New Talent for the Pharmaceutical Industry On February 26th, 2015, PROMETRIKA participated in the BU School of Public Health (BUSPH) Career Fair as part of its 10-year partnership with Boston University.

PROMETRIKA’s CEO, Miganush Stepanians, PhD, noted, “For PROMETRIKA, it is not only good corporate citizenship, it is a quick and effective way to be introduced to talented future leaders of the industry. BUSPH events are always well organized and are beneficial for our company and for the students.”

As in past years, PROMETRIKA had an opportunity to introduce more than 300 current BU students to the company’s expertise and values, and to the role CROs play in the biopharmaceutical industry. For more than 40 students, it was a unique chance to speak with PROMETRIKA Senior Biostatistician Linda Kasten. A statistician with over 25 years of experience and a BU graduate herself, Ms. Kasten provided insights into her role at PROMETRIKA and offered invaluable advice on career opportunities.

In addition to participating in the Career Fair, PROMETRIKA supports the BUSPH internship program. Each year, three or four BUSPH candidates for a PhD in biostatistics get practical industry experience at PROMETRIKA, working alongside experts in clinical trial data analyses.

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The PROMETRIKA team extends congratulations and best wishes to our own Dr. Jim MacDougall as he begins his tenure as President of the Boston Chapter of the American Statistical Association.

Dr. Jim MacDougallDr. Jim MacDougall, a biostatistician for 21 years, joined PROMETRIKA as a senior biostatistical consultant in early 2014. Dr. MacDougall has extensive experience in all phases of clinical research, including multiple regulatory submissions. As a departmental head and lead statistician, Dr. MacDougall has been responsible for the scientific and managerial success of complete clinical programs (phases 1 through 3 and submissions) in the therapeutic areas of gastroenterology, endocrinology, medical imaging, infectious disease, neurology, and women’s health. He has also been the lead statistician in many phase 1-2 oncology trials. Dr. MacDougall has been involved with many innovative statistical techniques for clinical trials, including a novel Bayesian approach using historical data to model and impute long-term disease progression.

Dr. MacDougall has prepared for, and presented at, FDA Advisory Committee meetings, and has presented at numerous scientific biopharmaceutical industry conferences. He is the lead or co author of many journal articles and author of a chapter in “Dose Finding in Drug Development”, published in 2006. Dr. MacDougall has been an active member of the Boston Chapter of the ASA for over 10 years.

Prior to joining PROMETRIKA, Dr. MacDougall served as Vice President of Biometrics at Ironwood Pharmaceuticals, which he joined in 2006. Prior to joining Ironwood, Dr. MacDougall held the position of Director of Biostatistics at Genzyme, Idenix, and Bristol-Myers Squibb Medical Imaging. Dr. MacDougall received his Doctor of Philosophy degree in Biostatistics from the University of North Carolina at Chapel Hill in 1999.

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Challenges of Implementing CDISC SDTM Standards for FDA Submissions
by Geeks Talk Clinical

Medidata’s Patrick Chassaigne  and PROMETRIKA’s Miganush Stepanians discuss key industry trends around data management, at the recent Partnerships in Clinical Trials conference in Las Vegas. In this video, Miganush foresees upcoming challenges for pharmas around the conversion of existing legacy data to CDISC standards for submissions. With the FDA now mandating CDISC SDTM standards, data should be submitted in CDISC format in order to be truly compliant. And although some companies are struggling with legacy data from paper-based or older systems that were not CDISC compatible, many tools are now being developed to tackle those challenges. Watch the clip for more from Patrick and Miganush.

*Guest blogger Miganush Stepanians, PhD is the President and CEO of PROMETRIKA, LLC a full-service CRO. 
*Guest blogger Patrick Chassaigne serves as CRO Partnerships Director at Medidata Solutions.

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PROMETRIKA Selects Medidata Solutions as Strategic Partner 

After working with Medidata Rave on nearly 20 studies, PROMETRIKA joined Medidata’s Partner Program as a Medidata Services Partner in order to meet growing sponsor and site demand for Medidata Rave®, the industry’s leading electronic data capture EDC) and clinical data management (CDM) system. In addition to Medidata’s market leadership, PROMETRIKA’s decision to partner with Medidata was also driven by Rave's standards-based approach to structured data, which allows for easy conversions of Rave-centric data into datasets for statistical analysis.

“Medidata clearly understands the business and operational challenges faced by our customer base – new and established biotechs that are working on some of the most innovative research in the world,” said Dr. Miganush Stepanians, president and CEO of PROMETRIKA. “We chose Medidata as a partner not only for its experience and expertise across the clinical development process, but also for its ability to help us continue to provide the most leading-edge technologies to
our sponsor customers.”

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PROMETRIKA helps a major cancer research institute standardize EDC databases and analysis procedures, leading to increased efficiencies in EDC startup timelines and costs

For a leading international cancer research institute, PROMETRIKA took the lead in revamping the database build process and devising standard oncology electronic case report forms (eCRFs) based on CDISC SDTM data structures.  Additionally, PROMETRIKA developed analysis datasets consistent with a common Statistical Analysis Plan across multiple studies.  

These datasets were made compliant with current CDISC ADaM standards.  Additionally, legacy datasets were mapped to common CDISC SDTM-compliant standards.

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