4C Pharma Solutions

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4C Pharma Solutions is a SPO (Service Processing Organization), owned and managed by Medical Doctors with years of domain expertise ranging from grass-root levels to managing operations at various Pharmaceutical manufacturers (ranging from small to large) and Pharmacovigilance Service Providers.

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https://www.4cpharma.com/
Type Private
Industry Pharmacovigilance, Argus Safety Database Hosting, ICSR Processing, Periodic Reporting, Medical Writing, Literature Search, Regulatory Affairs, Signal Detection, Risk Management, Medical Information, Safety Database Implementation, and Drug Safety Training
Founded 2014
Headquarters 15 Corporate Place South, Suite 402, Piscataway, New Jersey, USA. 08854
Key people Dr. Yathendra Madineni

CEO

Number of employees 11-50 employees <https://www.linkedin.com/company-beta/10026114/>

Services

  • Pharmacovigilance
  • Argus Hosting Solutions
  • Regulatory Affairs
  • Medical Writing
  • Medical Information Call Centre

Team With Hands On Domain Expertise

4C is established and operated by medical doctors with hands-on expertise gained from working at various top-20 drug/biological/device manufacturers and service providers bringing years of experience to 4C. This allows for very high quality work applying industry best practices making your responsibility truly our passion.

How We Do

We bring the best of the best practices from across industry and service providers to the process. We work as an extended arm of your company. 

The founders, being physicians, believe in a moral obligation to society by doing the work at a level that can help humanity. 4C, being defined by the 4 C’s: Complete, Correct, Consistent and Compliant, truly encompasses its belief of “making your responsibility into our passion.”

4C Advantage

  • Oracle Gold Partner
  • ISO 9001:2008 certified
  • ISO 27001:2013 certified
  • OSP certified
  • Fully installed in house Argus safety Database.

4C Services - Pharmacovigilance

ONGOING SUPPORT

  • Safety Development Plan – SOP writing, Data Migration, Implementation, Training
  • Case intake and Monitoring - Call centre activities for AEs, PQCs and MI, Validity, Duplicate check, Reportability, Triage
  • AE/ SAE/ processing – Data Entry, Coding, Narrative Writing, Validation, Medical Review, Submission, Follow-up, Compliance
  • Literature Search & Insights

PRE-DEFINED SUPPORT

  • Aggregate Reports – DSURs, PSURs, PADERs, PBRERs
  • Signal detection, prioritization, evaluation
  • Risk Management Plans (RMPs), REMS
  • Social Media Analytics for PMS and Spontaneous Adverse Events

ADHOC SUPPORT

  • Medical Monitoring
  • Risk-Benefit Assessment
  • Regulatory Authority Requests, Audit/ Inspection readiness, mock-audits
  • Health Care Analytics
  • Research Analytics and Insights

4C Services - Regulatory Affairs

    • Advice on Regulatory strategies for successful product market entries across the globe
    • Guidance for regulatory pathway that is necessary for timely regulatory approval
    • Advice on industry trends and current market needs
    • Advice on Regulatory Affairs and Regulatory Operations Outsourcing
    • Advice on the Regulatory mergers and acquisitions
    • Regulatory classification of products across different jurisdictions
    • Conduct face-to-face Meetings with Regulatory Authorities
    • Provide expert regulatory CMC compliance advice throughout development

4C Services - Argus Hosting Solutions

ARGUS SAFETY

  • Single case processing and expedited reporting
  • Integrated case management and workflow
  • Web-based, high-performance, high-availability system
  • Compliant with global safety requirements
  • Flexible configuration to model a wide range of business processes

DATA PROTECTION & CONFIDENTIALITY

  • The entire Argus Safety application, all its components and data, is partitioned by a unique enterprise ID (Client instance)
  • Users operate within this partition
  • Users can be assigned to access the enterprise for a specific client OR multiple clients (CRO case processing)
  • Users can see only the enterprise(s) for which they have access
  • If user has access to only one enterprise, then user can see only that enterprise after logging in to Argus and any other existing enterprises (created for other clients) will not be visible at all
  • Data of each enterprise is stored separately on cloud with partition to safeguard data confidentiality and integrity

4C Services - Medical Affairs

CLINICAL AND NON-CLINICAL

  • Study Protocols
  • Investigator Brochures
  • Patient Information including Informed Consent and Patient Brochures
  • ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
  • Summaries of Clinical Safety and Efficacy
  • Summaries of Non-Clinical Safety and Efficacy
  • Clinical and Non-Clinical Overviews
  • Safety Narratives

SCIENTIFIC COMMUNICATIONS

  • Conference materials (abstracts, poster presentations and slide decks)
  • Manuscripts
  • Editorial support
  • Journal/conference submission
  • Product website content (for both scientific and patient audience)
  • Educational material for patients, healthcare professionals and pharmaceutical industry personnel
  • Medical marketing reviews and reports
  • Literature Reviews

4C Services - Medical Information Call Centre

  • 24X7 Support
  • Global & Multilingual Support
  • Qualified HCPs for MICC
  • Inbound MI / AE / PQCs
  • Follow-up Calls
  • Targeted Questionnaires
  • Field Alert Reports
  • FAQs, MSLs and DHPC
  • Product Replacement & Refund Support
  • User-friendly Dashboard with Metrics


Recent Tweets

Top 5 Recent News Headlines

1. 4C Pharma Named In The Top 10 CROs -

http://www.4cpharma.com/News-Events/4c-pharma-named-as-the-top-10-cros/

2. 4C Pharma Solutions is at the 12th Pharmacovigilance Summit 2017 in London, UK tiny url. com /zhqx5e7 (www.linkedin.com)

3. 4C Pharma Solutions is proud to announce the launch of E2B(R3) compliant systems

https://www.prlog.org/12670773-4c-pharma-solutions-is-proud-to-announce-the-launch-of-e2br3-compliant-systems.html

4. 4C Pharma selects Oracle Argus Safety Cloud 8.1 to modernize and gain E2B(R3) compliance https://www.prlog.org/12677087-4c-pharma-selects-oracle-argus-safety-cloud-8-1-to-modernize-and-gain-e2br3-compliance.html

References

  1. https://www.4cpharma.com/

Verification history