Sciformix

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http://www.sciformix.com
Sciformix private limited.
Type Private
Industry Pharmaceuticals
Founded 2007
Headquarters Westborough, Massachusetts,US
Investors Manish and Ajit
Number of employees 1000-2000

About us

We are a leading Scientific Process Organization (SPO), providing scientific knowledge-based services to biopharmaceutical, generic pharmaceutical, consumer product, medical device, contract research and healthcare companies. We partner with our clients through the entire drug development cycle to provide a broad range of services from study design to post marketing surveillance and commercialization support. We deliver consistent quality and compliance across the services by employing scientific rigor in combination with streamlined process, optimal technology and efficient people practices and recently sciformix collabrated with Covance, it now it was known as Sciformix as a covance company.


SERVICES

  • Safety and Risk Management
    • Safety Consulting
    • Pharmacovigilance
    • Aggregate Reporting
    • Signal Detection and Risk Management
    • Safety Technology
  • Real World Evidence and Market Access
  • Clinical Research and Post Approval Support Services
    • Data Management
    • Biostatistics, Statistical Programming and Consulting
    • Clinical Research Support
    • Clinical Writing & Research Support
    • Market and Competitive Intelligence
    • Medical Information and Communication Support
  • Regulatory Affairs and Operations
    • Regulatory Strategy and Consulting
    • Regulatory Operations
    • Regulatory Writing
    • Product Labeling
  • Technology Services
    • IT Validation and Compliance Services
    • Laboratory Informatics Services

Pharmacovigilance

Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing phases from medical contact center to ICSRs to medical reviews to electronic regulatory submissions. Our highly skilled employees, including pharmacists, registered nurses and specialist doctors, perform case processing and medical reviews and are committed to meeting our client’s growing needs and acting as trusted partners. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical review and assessment of safety data. For clients who need advice and guidance at any point during the product lifecycle, they also act as trusted advisors over a wide gamut of consulting services.

Superior people, process and technology ensure superior quality and medical insight Emerging market expansion, company consolidations, market volatility, shrinking profit margins, heavy competition, growing regulatory pressure, the demand for more and better products and the need for more specialized resources are just some of the challenges the global life science industry is facing. To address these issues, organizations are changing their business models. They are leveraging economies of scale, capitalizing on synergies, and expanding their pipeline into new markets and new product categories. They are also increasing partnerships in areas previously considered proprietary, redefining corporate strategy via diversification versus specialization, and deliberately focusing on improving collaborations. And, they are increasingly leveraging outsourcing to enable focused excellence on their core business. Sciformix’s end-to-end pharmacovigilance services span clinical and post-marketing activities and our highly skilled individuals, from registered nurses to specialist doctors, perform case processing and medical reviews. Our excellence in people, tools and experience demonstrate our commitment to our customers’ growing needs. Our processes and flexibility allow us to quickly respond to fluctuations in your resource requirements. As a result, we deliver value to our clients by way of cost savings and process efficiencies. Furthermore, our experienced MDs and PhDs provide in-depth medical knowledge needed for medical interpretation of safety data. Our understanding of the day to day operations – from how a case is processed, to aggregating data, writing reports, and managing the regulatory reporting calendar – means that our processes and tools ensure 100% compliance to SLAs and regulatory guidelines. Our project managers track daily, weekly and monthly quality, productivity and efficiency metrics, and proactively work with our clients to strive to do better. Our expertise in technology and process automation provides us the ability to support and integrate multiple applications. By continuously improving our productivity, cost improvements and productivity gains can be transferred to the client. The winning combination of our highly skilled people, streamlined processes and innovative tools means that in daily peer reviews, medical reviews and reporting (in fact every workflow we touch) redundancies, gaps and delays are eliminated and there’s a smooth transition of the entire process with reduced overall timelines.

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