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Improving clinical trial efficiency
January 2017
by DDNews Staff  |  Email the author
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MONTREAL—Cincinnati-based contract research organization (CRO) Medpace has selected Montrium’s eTMF Connect and RegDocs Connect solutions for the management of Medpace’s clinical and regulatory documentation, which is said to already be improving clinical trial efficiency via a cloud-based document solution and enhancing their technology platform. Combined, these solutions form a comprehensive electronic document management system (EDMS).
 
“Medpace selected Montrium after evaluating several EDMS solutions available on the market. What we liked the most about the eTMF Connect and RegDocs Connect solutions, provided on the Montrium Connect platform, was the synergy between the system functionality and how we currently manage our clinical trials,” said Gary Rickels, director of information technology infrastructure and support at Medpace. “Montrium is a well-known knowledge leader for the CRO industry, and comes with a strong reputation for providing a robust solution set and supporting implementation and validation services. The added value in built-in configurable workflows, PDF conversion capability, a true EDM and TMF model structure built in, as well as digital signature technology, will give us the platform we need to continue our extensive growth.”
 
The Montrium Connect platform provides a collaborative environment for organizations engaging in clinical activity, allowing them to manage centrally all of the clinical, regulatory and quality documentation required by the regulatory agencies. Montrium Connect can be deployed in an on-premise deployment or via Montrium’s qualified GxP cloud hosted on Microsoft Azure.
 
“CROs play a critical role in clinical trials, and have emerged as integral stakeholders in the compilation of Trial Master Files and electronic submissions,” said Paul Fenton, president and CEO of Montrium. “We are excited to have been selected as a strategic partner of Medpace to help them empower their continued growth. Partnering with a clinical trial powerhouse such as Medpace attests to the maturity and comprehensiveness of our growing solution set.”
 
Medpace provides Phase 1-4 clinical development services to the biotechnology, pharmaceutical and medical device industries. It leverages its regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and antiviral and anti-infective, and the company employs approximately 2,300 people across 35 countries.
 
In other recent Medpace news, the company reported third-quarter financial results in November, noting that net service revenue for the three months ended Sept. 30, 2016, was $94.8 million, an increase of 16.1 percent compared to $81.6 million for the comparable prior-year period. Backlog as of Sept. 30 grew 14 percent to $480.4 million from $421.4 million as of September 2015. Net new business awards were $109.1 million, representing a net book-to-bill ratio of 1.15 times for the third quarter of 2016, as compared to $101.4 million for the comparable prior year period. The company calculates net book-to-bill ratio by dividing net new business awards by net service revenue.
 
For the nine months ended Sept. 30, 2016, net new business awards were $327.2 million, representing a book-to-bill ratio of 1.19 times, compared to $264 million for the nine months ended in September 2015. Net new business awards were higher in the nine months ended Sept. 30 in 2016 primarily due to continued growth in the company’s oncology, cardiovascular and antiviral/anti-infective therapeutic areas.
 
Medpace also announced in late November 2016 that it was presenting four scientific posters at the 2016 Annual Meeting and Exposition for the American Association of Pharmaceutical Scientists (AAPS).
 
Drs. Yong-xi Li, Guangchun Zhou and Tian-Sheng Lu of Medpace Bioanalytical Laboratories, along with Dr. Aiping Zhu—a Medpace analytical chemistry scientist—attended AAPS and presented the posters “Quantification of Nicotine and its Metabolite Cotinine in Rat Tooth, Rat Alveolar Bone and BrainUsing Triple Quad 5500 System,” “Simultaneous Quantification of Lathosterol, Lanosterol and Desmosterol in Human Plasma UsingUPLC-Tandem Mass Spectrometry,” “Simultaneous Measurement of Dehydroepiandrosterone (DHEA) and 17 Hydroxyprogesterone(17-OHP) as Biomarkers in Human Plasma using UPLC-MS/MS” and “Simultaneous Measurement of Four Oxysterols in Human Serum by UPLC-APCI-MS/MS.”
 
Code: E011726

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