Services

Professional Monitoring Services

TOXPLUS Monitoring offers three different tiers of study monitoring services to ensure your company complies with the oversite of studies conducted for drug development. We have study monitoring expertise for studies conducted to develop small and large molecules, biologics as well as cell and gene therapies.

Tox Plus Monitoring

Tier 1 - Single Study Monitoring Visit

Study Monitor will :

  • review the protocol with the Sponsor
  • provide onsite study oversite and inform the Sponsor of any issues during the visit
  • provide the Sponsor a monitoring report within a timely manner

The study monitor is not responsible for protocol development or reporting of the outcome of the study at this level of service

Tox Plus Monitoring

Tier 2 - Study Monitoring Plan for a Complete Study

Develop a Study Monitoring Plan for a Single Study

  • review the protocol with the Sponsor
  • agree mutually on a study monitoring schedule for the study (number of visits may vary depending on study type)
  • provide onsite oversite of the study and inform the Sponsor of any issues during the visit
  • provide in-life monitoring of the study remotely
  • provide the Sponsor updates on a regular basis and
  • provide Sponsor with monitoring reports after each visit within a timely manner
Tox Plus Monitoring

Tier 3 - Study Monitoring for a Complete Program

Develop a Study Monitoring Plan for a Single Study

  • This Tier of Services provides Study Monitoring for all studies within a program
  • May include assistance with CRO Selection, CRO qualification
  • The Sponsor and the Study Monitor will agree on a Study Monitoring Schedule and number of visits per study
  • In life monitor of the studies remotely and provide updates to the Sponsor on a regular¬†basis
  • Study Monitor provides Sponsor with Monitoring reports within a timely manner after each monitoring visit

Additional Services Offered

  • CRO Study Quotes
  • CRO Qualification
  • GLP audit
  • Data audit
  • Program development services, including protocol development, data review and interpretation as well as report review/editing, are offered upon request.
Tox Plus Monitoring