SERVICES&CASE

SERVICE

Data Management and Biostatistics

We offer around-the-clock support for Biostatistics and Data Management at competitive pricing!

With office locations in China and the USA (Fort Washington, Pennsylvania) we offer around-the-clock support for Biostatistic Analysis, SAS Programming and Data Management. 

Our 24/7 model is a low cost alternative to engaging a Sponsor, then pulling together the right resources. Our team of global experts has the capacity to meet the demands of large and small biotechnology and pharmaceutical companies while maintaining industry standards.  FMD has implemented rigorous operating procedures and manages projects in the U.S. and China in a non-compromising manner that meets Sponsor demands and global Regulatory requirements. We take pride in our ability to provide high quality, on time and within budget.

In the past 24 months, our team has been involved in multiple NDA Submissions, many of which have been approved by U.S. FDA, CFDA, and other regulatory agencies. . We have designed and built Phase I-IV trials and developed innovative solutions to complex challenges. This remarkable track record is based on many years of working with the FDA, the CFDA and other regulatory agencies around the world.  Our longstanding industry knowledge and commitment to excellence has proven successful, and has gained the praise of many leading biotechnology and pharmaceutical executives.  The FMD team understands the necessary outcomes that help get needed drugs, vaccines and devices approved in today's fast paced, demanding clinical and regulatory environment. 

Data entry, Database building & Query management
A high quality data collection depends on the Data Management System, well defined processes, as well as a strong and experienced team. Fountain can support both EDC and paper studies. For EDC studies, Fountain is one of two local CROs that can support the design and implementation in MediData Rave, and also one of the three local CROs that can support the design and implementation in Oracle Inform. For paper studies, Fountain is using Open Clinica Enterprise edition to provide full 21 CFR Part 11 compliant Data Management services. Fountain has 25 Data Management SOPs that provide the detail process for every aspect of Data Management area. The leaders of our Data Management team are industry veterans with more than 10 years of experience working in the pharmaceutical industry. Our system, process, and personnel have been audited by many global pharmaceutical companies around the world. In 2012, our Data Management team was chosen as the global outsourcing partner for a top 5 pharmaceutical company. We are the only local CRO that has been awarded this type of global Data Management outsourcing project in China.

 Statistical planning, SAS Programming & Reporting
FMD fully understands that biostatistics plays a key role in pharmaceutical R&D including clinical trials, regulatory approvals and market research. Biostatisticians require special expertise and experience.  Our statistical team consists of experts with rich experience in both global and domestic trials. Most of our Ph.D. level biostatisticians have more than 10 years of industry experience in a broad range of therapeutic areas. FMD will provide a statistical analysis plan (SAP) for this project and will also perform programming in advance. Fountain will provide Chinese and English versions of the statistical analysis reports.

 EDC
• We are an accredited service provider of the industry’s leading MediData Rave system.
• Also certified to do study build in Oracle Inform and Oracle Clinical. 
• We use Open Clinica for academic based research trials and are familiar with other small EDC vendors


CDISC (Clinical Data Interchange Standards Consortium) Used to standardized clinical research data
• CDISC gold member and CDISC Registered Solution Provider.

 

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