FIRMPLACE

How we do it

Firmplace Corp. is setup to support Clinical Research Organizations and their sponsors offering Data Management, Biostatistics, Statistical Programming, and Medical Writing services as well as CDISC compliant services to the pharmaceutical, biotechnology and medical device industries worldwide. Our services encompass end-to-end solutions utilizing industry data standards and rigorous operating procedures that enhance our Clients' ability to get their products approved faster, at minimum risk and lower cost in order to meet patients' needs for advanced medicines.

 

Firmplace's team of industry experts offers highly successful, timely proven capabilities that minimize transformation, re-work, and unwanted errors. Some of the highly specialized areas in which we can help your organization meet its approval and regulatory needs include:

·         Adaptive and Traditional Trial Design

·         Protocol Development

·         Statistical Analysis Plan Development

·         EDC Implementation - Medidata Rave, Oracle OC/RDC, Oracle InForm and OpenClinica

·         Data Management - Data Standardization (CDASH) for Clinical Studies Phase IIV

·         Biostatistics - Interim Analysis, Data Monitoring Committee (DMC) Support, Top Line Reviews and CSR Support

·         SAS Programming - SDTM/ADaM Datasets, TLFs and ISS/ISE Support

·         Compliant eSubmisson Data Package Preparation - SDTM annotated CRF, define.pdf or define.xml

·         Medical Writing - Multiple Therapeutic Areas including Oncology, Neurology, Cardiovascular and Immunology

·         Data Safety Monitoring Committee Support

·         Safety Surveillance

·         Pharmacovigilance Support

 

 

For over a decade we have successfully assisted Sponsors and CROs with on‐site, project‐based or Functional Service Provider (FSP) support for Phase I‐IV clinical studies, as well as post‐marketing pharmacovigilance support and outcome research.


 

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