Services offered for Investigators and Sponsors

Limestone CTU offers the following clinical trial services to investigators and sponsors and can work with the investigators and sponsors to identify services required for each trial.

Trial Selection

  • The CTU can help the investigators with review of the clinical trial / study to assess feasibility of conducting the study

  • The CTU will help the investigators review the budget of the clinical trial and ensure that the funds are sufficient to execute the commitments of the trial protocol

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Approvals

  • CTU will support the investigators in ethics submission to local IRB or CTO.

  • CTU will support in submission of the application for obtaining the institutional approval as well as collaborate with the institutional delegates to clarify any queries and obtain the required approval

  • CTU will support the investigators for legal contract review

Startup

  • The CTU will help support the site initiation visit

  • The CTU will help with the study startup

  • CTU will provide necessary Standard operating protocols for the clinical trials

Screening & Enrolment

  • The CTU staff will handle the informed consent process as per the study protocol

  • The CTU staff will screen the participants after obtaining the consent and handle all documentation required

  • CTU staff will enrol and randomization of the participant as per the study protocol

Data Handling

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  • CTU staff will collect the study data as specified in the protocol

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Pharmaceutical

  • The CTU will ensure appropriate temperature controlled storage, monitoring, and audit logs for any pharmaceutical products. CTU will also communicate with the sponsor and investigator about any temperature excursions and take appropriate necessary steps

  • CTU will support with dispensing of study interventions as per the study protocol. CTU will liase with the investigators and other members of the circle of care (physicians, nurses and pharmacy) to ensure transparent and effective communication

  • CTU will also ensure appropriate destruction of unused study medications as per the study protocol

Logistics

  • The CTU can handle the shipping and receiving of study documents, study supplies, biological specimens.

Patient engagement

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Laboratory Services

  • CTU staff will support with collection of any biological specimens or samples as per the study protocol

Follow-Up Visits

  • The CTU can liase with the patients and their caregivers to schedule study visits

  • The CTU will handle the reimbursement of any payments to the study participants as specified in the protocol.

  • The CTU will also arrange for any transportation (Taxi, Access bus) for the study participant , budget permitting.

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Compliance

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Study Close-Out

  • CTU will support the investigators in archival of documents according to Health Canada / FDA specifications.