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| 2010 |
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Canton, MI – MMS Holdings, Inc. is pleased to announce our 2010 Summer Symposium, to be held on Tuesday, August 3rd, 2010 at the MMS global headquarters in Canton, Michigan. This event is open to our pharmaceutical and biotech colleagues. We welcome you to join our MMS staff and Advisory Board Members.
Please view our 2010 Summer Symposium flyer click here
To learn more about presenters click here
We ask that you register to attend by completing the registration form below (attendance is free of charge).
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Canton, MI (April 5, 2010) – Dr. Harrigan is a board certified neurologist and has been in the pharmaceutical industry for the past 20 years. He has held various positions with leadership responsibilities in clinical, regulatory and business development lines at 4 pharmaceutical companies and held senior level positions in executive management. He also has 7 years experience in private medical practice as a neurologist.
Dr. Harrigan most recently held the position of senior vice president at Pfizer Inc in the litigation department as a consultant to the Pfizer’s legal division. Prior to that, he held various positions at Pfizer as senior vice president in the medical division; head of worldwide business development; head of worldwide regulatory affairs & quality assurance; and various leadership roles in Phase II-IV clinical development for the neuroscience, pain and ophthalmology areas. He also recently served with Project HOPE in Shanghai, China as a Pfizer Global Health Fellow.
As a member of MMS’ scientific advisory board, Ed will utilize his broad experience in the support of MMS teams.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001 certified for all services and maintains detailed quality metrics for every project. For more information visit: http://www.mmsholdings.com
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Canton, MI (February 22, 2010) – MMS Holdings is pleased to announce the addition of Dr. Robin J. McGarry to its scientific board. Robin is a nephrologist by training and has been in the pharmaceutical industry for the past 24 years where she has been involved with various aspects of drug development at 4 pharmaceutical companies and has 10 years of experience as an independent clinical and regulatory consultant. She is experienced with US and global medical/regulatory strategy for pharmaceutical products in development and marketed products, post-marketing pharmacovigilance, risk management, product defense, U.S. and European safety and efficacy submissions and FDA post-marketing safety compliance issues. Dr. McGarry was Vice-President of Worldwide Safety at Pfizer for over 4 years where she led and managed over 300 employees responsible for worldwide collection and regulatory reporting of safety information and product support for Pfizer’s marketed products, including pharmacovigilance, epidemiology, and worldwide labeling, oversight of corporate safety database development and management of FDA compliance activities.
As a member of MMS’ scientific advisory board, Robin will support MMS teams and clients with REMS, Risk Map development and other PV activities and provide oversight for regulatory submissions developed at MMS.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001 certified for all services and maintains detailed quality metrics for every project. For more information visit: http://www.mmsholdings.com
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| 2009 |
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BioClinica, Inc. is a leading global provider of integrated, technology-enhanced clinical trial services. BioClinica supports pharmaceutical and medical device innovation with imaging core lab, internet image transport, electronic data capture, interactive voice and web response, and clinical supply chain design and optimization solutions. BioClinica services maximize efficiency and manageability throughout all phases of the clinical trial process. With more than 2,000 successful trials to date, BioClinica has supported the clinical development of many new medicines from early phase trials through final approval. BioClinica operates state-of-the-art, regulatory-body-compliant imaging core labs on two continents, and supports worldwide eClinical and data management services from offices in the United States and Europe. For more information, please visit www.bioclinica.com
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Canton, MI. (September 2, 2009) – Uma Sharma, Ph.D., Chief Scientific Officer at MMS Holdings Inc., will present at the DIA’s 4th Annual Conference on Drug Discovery and Clinical Development in India: Scientific and Regulatory Advances Across Borders. Dr. Sharma will not only be presenting in the main conference but will also be giving a workshop on medical writing. For more information on the conference please visit www.diahome.org.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001 certified for all services and maintains detailed quality metrics for every project. For more information visit: http://www.mmsholdings.com
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Canton, MI. (September 1, 2009) - MMS Holdings Inc., a pharmaceutical service organization, announces the hosting of the Michigan SAS Users Group (MISUG) Fall meeting. The MISUG is organized to further the interests of programmers and users of the SAS Software System in Michigan. Members share information on building applications with SAS Software and how to better use programming tools and user interfaces. This meeting will occur on November 5th, 2009 from 2PM to 4:30PM. Among other distinguished speakers, Michelle Gayari, Director of Operations at MMS, will give a presentation on “Utilizing SAS for Efficient Coding.” The cost is free and open to all those interested in attending. Please go to www.misug.com to find out more information on this great event.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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Canton, MI. (August 10, 2009) – MMS Holdings Inc., a pharmaceutical service provider, has conducted training sessions on eCTD’s at The Regulatory Affairs Professionals Society (RAPS), the world’s largest international membership organization of regulatory professionals in the medical device, pharmaceutical, and biotechnology sectors, on August 6-7, 2009. The topics of the training sessions included Efficacy (Clinical) Overview, Module 5 Case Report Forms (CRFs) and Datasets, and Clinical Data Interchange Standards Consortium (CDISC) Presentations were lead by Uma Sharma Ph. D., Chief Scientific Officer, Michelle Gayari, Director of Clinical Programming and Biostatistics, and Antoinette Azevedo, Founder e-Submission Solutions. These training sessions were focused on individuals in the medical device, pharmaceutical, and biotechnology industries that are interested in learning and understanding the building blocks for a successful electronic submission.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
About RAPS
The Regulatory Affairs Professionals Society (RAPS) is an international membership organization of regulatory professionals in the rapidly growing medical device, pharmaceutical and biotechnology sectors. As regulatory professionals, RAPS members perform vital work in all areas of the healthcare product lifecycle, ensuring these products are safe and effective, while driving organizational strategy and sound decision-making. RAPS supports these individuals and the regulatory profession as a whole by providing education and training, certification, professional standards, research, knowledge-sharing, publications, networking and career development opportunities and other valuable resources; and is committed to helping its members continually develop the knowledge and skills they need to excel. For more information visit: www.RAPS.org
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Canton, MI (June 01, 2009) - MMS Holdings Inc., a leading pharmaceutical service organization, is pleased to announce the addition of Dr. Ethan Weiner to its scientific board. Dr. Weiner has 20 years of drug development experience at Pfizer where he was most recently Senior Vice President. During the course of his career he has been involved in all aspects of the development of drugs and biologics. This work spanned early and late phases of development and involved working with the discovery and commercial organizations to create therapeutic area strategies, product profiles, and development plans to achieve these profiles for specific molecules. Dr. Weiner also supported in-licensing and out-licensing of multiple drug candidates. He is experienced in several therapeutic areas (inflammation, pain, infectious diseases, pulmonary diseases, ophthalmology and oncology) as well as multiple geographic regions including Japan and Asia as well as North America and Europe.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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Washington DC (March 18, 2009) - At the 110th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT), Spaulding Clinical and MMS Holdings Inc. announced a strategic partnership to promote an integrated suite of advanced technologies and services to optimize Phase 1 study support. This alliance will facilitate comprehensive study design, synopsis/protocol authoring, study execution, data management, statistical programming and analysis, and Clinical Study Report interpretation and writing – all integrated in one seamless electronic data flow. This means that sponsors do not have to pay for costly and error-prone data transfers but instead work with one vendor and one source of study data for all their study needs. Additionally, this fully integrated approach enables Spaulding to analyze study data in real-time, providing invaluable quality control feedback for immediate correction—while the subjects are still being monitored.
Spaulding Clinical is a Phase 1 clinical trial facility with state-of-the-art services utilizing the most advanced technologies available to monitor, record, analyze and report trial data. With our unique specialization in cardiac safety testing for new drugs in development, Spaulding Clinical provides the highest quality clinical trial conduct—using the most efficient processes in the industry—resulting in the most accurate data possible.
“We are very excited to add MMS Holding’s Inc. capabilities to our comprehensive list of Phase 1 services,” noted Daniel Selness, Vice President of Operations, Spaulding Clinical. “As a robust clinical service provider, MMS Holdings Inc. is built on a strong foundation of science and quality and has a proven track record of delivering strong results for their clients. They are uniquely positioned to support Sponsors in data analyses, medical writing and overall development. Their expertise in regulatory requirements and submissions creates a high value to this partnership, keeping in mind the end-goal of a successful regulatory submission for our clients.”
“This partnership represents a significant milestone for us,” said Uma Sharma, Chief Scientific Officer for MMS Holdings Inc. “Spaulding Clinical shares our commitment to scientific excellence and innovative solutions. Well-planned and well-conducted phase 1 trials, especially in the area of cardiac safety, are of great importance to our clients and to regulators, and Spaulding Clinical provides the necessary scientific, operational and technological expertise in this area. We are very impressed with the Spaulding team and our combined strengths will bring increased value and high quality results to our clients; who in turn can deliver promising medications to patients who need them.”
About Spaulding Clinical
Spaulding Clinical is Phase 1 Clinical Research Unit and Cardiac Core Lab located in West Bend Wisconsin. Spaulding Clinical offers a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, PK/PD characterization and data collection and management. Spaulding Clinical also offers a full suite of Cardiac Core Lab and Over-reading services with state-of-the art technology and cardiac expertise. For more information visit: www.spauldingclinical.com.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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Canton, MI. (March 12, 2009) - MMS Holdings Inc., a pharmaceutical service provider, is pleased to announce that they presented at the 24th Annual DIA Data Conference and Exhibition: Clinical Data Lifecycle Trial Design through Submission and Beyond. Michelle Gayari, Director of Operations at MMS, gave a presentation on March 10, 2009 entitled “Legacy Clinical Trial Data: Challenges and Solutions.” During the informative presentation Michelle Gayari spoke on the problems, the reasons for using, standards, case studies, and the organization of legacy data based on MMS’ experience in this area. MMS has extensive experience in creating submission datasets from complex source data including legacy studies. The event was held in Philadelphia, Pennsylvania from March 9 through March 11, 2009.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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| 2008 |
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Canton, MI (October 28, 2008) - MMS Holdings Inc., a pharmaceutical service organization, announces membership in CDISC. CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. Senior MMS staff actively participates and present at forums wherein CDISC topics are discussed.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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Canton, MI (October 8, 2008) - MMS Holdings Inc., a pharmaceutical service organization, and 3D Communications, a media relations company specializing in FDA advisory committee meetings, combine their strengths to support pharmaceutical sponsors in the areas of FDA AC briefing documents and FDA regulatory responses. 3D and MMS have supported several ACs and look forward to more successful meetings across a variety of indications.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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Canton, MI (September 1, 2008) - MMS Holdings Inc. and e-Submissions Solutions.com announce the formation of a collaborative alliance to provide services to pharmaceutical sponsors in the area of eCTD publishing for regulatory submissions. MMS routinely drafts CTD components for its sponsors and this alliance with eCTD publishing will allow sponsors to receive a complete submission-ready CTD for their compounds.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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Canton, MI (July 09, 2008) – MMS Holdings Inc., a pharmaceutical service provider, is pleased to announce their award for Best Paper at PharmaSUG 2008. PharmaSUG, the Pharmaceutical Industry SAS® Users Group, is a place where SAS® users can come together to share and develop new ideas relating to quantitative health science industries such as the pharmaceutical industry. The paper won in the Statistics and PK category and is titled Approximate Simultaneous Nonparametric Confidence Intervals for All Pair-Wise Comparisons and Comparisons with a Designated (Control) Group in a One-Way Layout Using the SAS® System. The award-winning paper was a collaborative effort at MMS Holdings inc. and was written by colleagues Paul Juneau, Aditya Sikka, Jiawei Qiao and Michelle Gayari. To see a PDF of the award click here.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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| 2007 |
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Canton, MI. (February 17, 2007) – MMS Holdings Inc., a pharmaceutical service organization, is pleased to announce that they are expanding their operations to Asia by opening a satellite office in Bangalore, India. The company is experiencing exceptional growth while still keeping quality at the forefront of every product and service they deliver. The global presence will allow MMS to better serve their client base and allow for additional growth opportunities.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com |
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| 2006 |
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Canton, MI. (October 27, 2006) – MMS Holdings Inc., a pharmaceutical service organization, is pleased to announce they have gained their first ISO certification. The International Standardization organization (ISO) is the world’s largest, non-governmental standards organization. Any company that has attained an ISO certification is guaranteed to have a high level of quality in every aspect of their business. The audit process was conducted by TUVRheinland®, a global independent certification corporation, over a period of two days from October 19 to 20, 2006.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2000 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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Canton, MI (September 1, 2006) – MMS Holdings Inc., a pharmaceutical service organization, announces the use of Microsoft® SharePoint® as a document management system. SharePoint® allows the employees of an organization to collaborate with their colleagues throughout the organization. Here, important client and internal documents can be stored for others, with granted access, to view and use. With the use of document libraries and lists, the users at MMS Holdings Inc. can now work more effectively and efficiently due the fact that all important project documents are well organized and in one central location.
About MMS Holdings Inc.
MMS Holdings Inc. is based in Canton, MI and is a highly experienced pharmaceutical service organization that is focused on quality deliverables in the areas of Clinical Programming, Biostatistics, Medical /Regulatory Writing and Comprehensive Pharmacovigilance. Commitment to Quality deliverables with robust submission experience sets MMS apart from traditional service providers. MMS Holdings Inc. is ISO-9001:2008 certified for all services and maintains detailed quality metrics for every project. For more information visit: www.mmsholdings.com
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