Quanticate

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Quanticate
Industry CRO
Founded 1994
Slogan A Passion for Excellence
Headquarters Hertfordshire, UK; North Carolina, USA
Number of employees 280 +
Quanticate is a leading global data-focused Clinical Research Organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance.

As Experts in Clinical Data, Quanticate provides high quality teams that offer efficient outsourcing solutions for clinical data management, biostatistics, statistical programming, source data verification, medical writing and pharmacovigilance.  Quanticate can offer study level support, functional service provision (FSP), strategic full data-services solutions or technical consultancy to meet the needs of pharmaceutical, biotechnology and device companies across the globe. By offering high quality, value-add client specific solutions to meet current and future development needs, Quanticate has become the supplier of choice for many companies from Top tier pharmaceutical giants through to niche biotechnology and device companies[1] .

History

1994 as Statwood, Quanticate was formed through the coming together of Statwood and Oxford Pharmaceutical Sciences (OPS) in 2007.

Services

  • Biostatistics
  • Statistical Programming
  • Clinical Data Management
  • Medical Writing
  • Pharmacovigilance
  • Consultancy

Clinical Trial Pharmacovigilance

From Phase I to IV Quanticate covers drug and vaccine safety right through to the development cycle ensuring that ICH Good Clinical Practices are fulfilled. Quanticate offer the following pharmacovigilance services:

  1. PV Consultancy and Project Management
  2. Serious Adverse Event Case Processing of Initial/Follow-up reports
  3. MedDRA coding
  4. Case Narratives
  5. Medical Monitoring
  6. Global Expedited Case Reporting
  7. EudraVigilance reporting using EVWEB
  8. Responsible Person for EudraVigilance
  9. Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) entry and maintenance
  10. Safety Data Management & Global Safety Database - Oracle Argus
  11. Legacy case transfer
  12. Signal Detection & Evaluation
  13. Development Safety Update Report (DSUR) preparation and submission
  14. Global Literature Search & Review in support of the DSUR
  15. Pharmacovigilance Quality Assurance including SOP development
  16. Monthly compliance and status reporting
  17. Pharmacovigilance Awareness Training
  18. Reconciliation of Serious Adverse Events
  19. Risk Management
  20. Study documentation review and update, including protocol and Investigator’s Brochure


Top Facts

HEADQUARTERS: Hertfordshire, UK; North Carolina, USA

OTHER LOCATIONS: Manchester, UK; Edinburgh, Scotland; Bangalore, India; Warsaw, Poland; Bloemfontein, South Africa

WORK BREAKDOWN: Programming 48%, Medical Writing 7%, Pharmacovigilance 6%, Statistics 24%, Clinical Data Management 15%

KEY ACCOMPLISHMENTS: CRO Leadership Awards 2013 (Innovation), CRO Leadership Awards 2014 (Quality, Reliability,Productivity, Regulatory and Innovation), CRO Leadership Awards 2015 (Quality, Productivity, Regulatory and Innovation).


Top 5 Recent Tweets

DateAuthorComment
October 20, 2020QuanticateAn excellent piece by Deepu Joseph for @Clin_Trials exploring #Biometric functional services and the significant im… https://t.co/2N22mPOBxn
October 19, 2020QuanticateWe provide a checklist that is worth applying at the very beginning of #Programming work – these can be used in add… https://t.co/SqXE9hPTid
October 18, 2020Quanticate[FREE WHITEPAPER] Want to know the benefits of using a #Pharmacokinetics Handover Document in #PK Studies? This doc… https://t.co/vc7hb9tiCj
October 17, 2020Quanticate[Case Study] A useful account of an ISS and ISE production for an orphan drug. https://t.co/FBh08JInlN #clinicaltrials #drugdevelopment


Top 5 Recent News Headlines

Top 5 Lifetime Tweets

Top 5 Lifetime News Headlines

  1. https://www.quanticate.com/globalcro

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