A Reputation for Industry Knowledge

QPharma’s principal consultants, brand specialists, and executives include many sought-after Key Opinion Leaders in the life sciences industry.  Check back often for white papers, articles, and updates on our thought leadership activities.

2016 Transparency Reporting Date Calendar

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The 2016 federal and state reporting dates for last year’s transfers of value to covered Sunshine Act recipients are fast approaching.

Federal reports are due in March; individual state reporting dates follow in April, May, and July.  Download and print this handy one-page calendar to keep the key submission dates close at hand.

QPharma is an industry leader in the delivery of aggregate spend and Sunshine Act reporting.  Learn more about our QSpend® solution.


Dissecting Electronic Signatures for the Life Sciences

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QPharma enjoys a longstanding reputation for the expertise of its personnel on the topic of 21 CFR Part 11 and electronic signatures for the life sciences industry.  In this article, featured in the January 2016 edition of Journal of Clinical Research Best Practices, QPharma Director of IT Compliance Robert Finamore and co-author John Harris outline the requirements for electronic signatures in conducting clinical trials.

Download the article as a PDF file.


QPharma Case Study: Effective Alternative Sampling

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QPharma is a leader in the delivery of top-quality hand-carry and sample-send (Direct to Practitioner) sampling programs.  But it is equally important that pharmaceutical companies implement effective alternative sampling programs to target low-decile, no-see, and other “white space” healthcare practitioners.  In this short case study, QPharma Director of Patient Access Michael Milunec outlines a sampling obstacle one of our life sciences clients was facing, and the solution QPharma implemented to solve its brand challenges.

Download the case study as a PDF file.


Using “Knowledge Mobilization” to Motivate a Pharma Sales Team

QPharma Chief Medical Officer Dr. Peter Shaw recently developed and conducted a sales force training at a pharma client’s National Sales Meeting.  The training was based on a comprehensive physician survey to gain an improved understanding of physician communication preferences. This brief white paper describes the problem our client faced, and QPharma’s effective solution.

Download the white paper as a PDF file.

2015 Aggregate Spend Reporting Date Calendar

The 2015 federal and state reporting dates for last year’s Aggregate Spend transactions are fast approaching.

Federal reports are due in March; individual state reporting dates follow in April, May, July, and October.  Download and print this handy one-page calendar to keep the key submission dates close at hand.

QPharma is an industry leader in the delivery of aggregate spend and Sunshine Act reporting.  Learn more about our QSpend® solution.

The Opioid Dilemma: Guiding Physicians to Compliance

Matt Crusan, QPharma’s Director of DEA Compliance and Services, provides guidance to attorneys who are facing the unfamiliar territory of advising physician clients on navigating DEA regulations. Read more ….

Establishing Robust SOM Programs

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QPharma Director of DEA Compliance and Services Matt Crusan offers insight into the steps necessary for pharmaceutical companies to develop a robust, effective Suspicious Order Monitoring program.

A former Diversion Investigator with the Drug Enforcement Administration (DEA), Crusan brings his extensive knowledge of DEA regulatory policy to his role as head of QPharma’s newly established DEA compliance practice. Read more ….


QPharma Subject Matter Experts Featured in Online Radio Interview

Scott Collins and Paul Melamud of QPharma’s Professional Services group were recently interviewed on the topic of manufacturing facility and equipment compliance.  The online radio interview is featured on   Pharmaceutical Online and will be broadcast at the INTERPHEX conference in New York City on March 18 – 20.  Hear the interview now.

QPharma’s Sunshine Act Survey Featured in Pharmaceutical Commerce

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A survey conducted by QPharma to gauge physicians’ understanding of the Physician Payment Sunshine Act was highlighted in the November/December 2013 issue of Pharmaceutical Commerce.  The findings were presented at the PDMA Sharing Conference, which was held in Baltimore in October.

Download the article as a PDF file.


QPharma’s Medical Device Division Offers Guidance on UDI Final Rule

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On Friday, September 20, the final Unique Device Identifier (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland.  Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement. Read more ….

A Comparison of Process Validation Standards

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Jeff Boatman, QPharma’s Senior Subject Matter Expert, Medical Devices and Quality Systems, has authored an article titled “A Comparison of Process Validation Standards” that is featured in the May/June issue of Pharmaceutical Engineering, the technical journal of the International Society for Pharmaceutical Engineering.

Download the article as a PDF file.


The Sunshine Act Has Been Finalized … What Has Changed?

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In February 2013, the Center for Medicare and Medicaid Services released the final rule of the Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics, or medical supplies to disclose transfers of value to physicians and teaching hospitals. Read More ….

Investing in Compliance

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You’ve probably taken an online compliance training course at one time in your career.  Did you click through in record time, then try your best to pass the assessment?  Don’t be ashamed if your answer is “yes” — you aren’t alone. Read More ….

QPharma White Paper: GHTF and FDA Validation Guidance

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QPharma’s Jeff Boatman, CQA, Senior Subject Matter Expert, authored a white paper examining the Global Harmonization Task Force’s process validation standard and how it compares to current best practices and FDA regulatory requirements for medical devices.

Download the white paper as a PDF file.


Robert Finamore Presents at Dreamforce Conference

QPharma’s Robert Finamore co-presented a Cloud Computing workshop titled “Meeting the Challenges of Regulatory Oversight” at Dreamforce 2012, which was held in September in San Francisco.
To learn more about Thought Leadership at QPharma, please contact us.