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Services : Research Services : Regulatory
MMS Holdings Inc.Go Back  


Address:
6880 Commerce Blvd.
Canton, MI 48187
UNITED STATES
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Contact Info:
T: (734) 245-0167
F: (734) 245-0170

Company Contacts:
Don McLean
Business Associate

Website URL:
www.mmsholdings.com/

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Organization:
MMS Holdings Inc.

About Us
MMS Holdings Inc. is an ISO 9001:2008 Certified organization located in Canton, Michigan. We provide clinical development support, medical writing, clinical programming, biostatistics and regulatory affairs services to the pharmaceutical, biotechnology and medical device industry. Quality and commitment are the hallmarks of our success and every project we complete reflects our core values and principles.

Products / Services:


Clinical Development Services:
-Identification of investigational sites
-Feasibility survey support for global studies
-Regulatory strategies for global study conduct
-Clinical Development Plan (CDP) support and maintenance
-Protocol development
-Case report form design
-Informed consent document development and update
-Consolidated IRB submissions for all sites and maintenance
of approvals
-Ongoing recruitment support and solutions for enhanced
recruitment

Clinical Programming and Biostatistics:
-Clinical Programming Services
-Statistical Consulting Services

Regulatory Services:
-Provide guidance and support to new and ongoing
development programs
-Create proactive or reactive regulatory strategies to
respond to anticipated or unforeseen regulatory hurdles
-Planning and preparation for successful agency meetings
-Planning and development of global submissions
-Global labeling development

Medical Writing Services:
-Clinical Documents
-Regulatory Documents
-Pharmacovigilance Documents
-Other Documents

Drug Safety Services:
-Management of safety databases including data migration services
-24/7 call center
-SAE management and expedited reporting
-Safety narratives and summaries
-Ad hoc safety analyses and risk management
-Signal detection
-Annual reports
-PSURs
-Expert reports
-Labeling/CCDS support
-Literature review


Other Categories this company can be located in
Clinical Research Organizations
Contract Research
Data Analysis and Management
Health and Safety
Research Services

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