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Meet the Team
Clinical trial

Services

Our mission here at Derby CTSU is to ensure that studies are well-designed, efficiently managed to budget and time, fully-compliant with all applicable regulation and guidelines, and to deliver high quality results and publications.

We recommend that you approach us at least 3 months prior to a funding application deadline, however if you wish to contact us earlier for information, we’d be happy to help.  We can assist if you have an idea for a research study, or if you are preparing a funding application and would like to collaborate with us, please complete the ‘Request for DCTSU Collaboration Form’ and a draft study summary, protocol or funding application.  Your application will be reviewed by the Operational Group and we will aim to respond to you within 14 days.

See CONTACT US page for email or DCTSU address.

We offer the following support services conducted by experienced and qualified personnel, either as a complete package or to suit your requirements:

  • Assist with the development and registration in PROSPERO of the systematic literature review protocol.
  • Conduct searches of relevant national and international databases for on-going and active studies.
  • Help with the development of the data collection tool for the systematic review.
  • Identify and support funding applications. 
  • Conduct meta-analysis.
  • Assist in preparing the systematic review results for publication.
  • Identifying a funding stream(s) and assist with funding applications. 
  • Support with grant writing. 
  • Refinement of research aims, objectives, outcome measures and end points. 
  • Review of study protocol. 
  • Aiding in appropriate study design and methodology. 
  • Ensuring compliance with regulatory requirements.
  •  Advice on resource requirements, including cost attribution. 
  • Coordination of peer review and PPI review.
  • Risk assessment.
  • Development of study specific documents.
  • Application to the HRA, REC, MHRA and sites for approval and maintaining approvals following study amendments.
  • Registration with EudraCT.
  • Registration with a publically accessible database.
  • Advice on obtaining honorary NHS contracts/ research passports.
  • Site initiation visits.
  • Training.
  • Set-up of trial master file and investigator site files.
  • Writing or review of trial management plan.
  • Central trial management including communication with sites and preparation of newsletters.
  • Central and on-site monitoring including SDV (development of the monitoring plan).
  • Adverse event monitoring and reporting.
  • Quality Assurance and audit.
  • Organisation of Trial Management Group (TMG), Trial Steering Committee (TSC) and Data Monitoring & Ethics Committee (DMEC) meetings (including preparation of reports).
  • Audit and inspection readiness.
  • Completion of reports for funding bodies, Sponsor, REC, MHRA.
  • Close out of sites.
  • Advise on production, formulation, blinding, shipment, storage, dispensing and management of Investigational Medicinal Product (IMP).
  • IMP and placebo procurement.
  • Development of the pharmacy manual.
  • Procedure for emergency unblinding.
  • Design of case report forms.
  • Database design, programming, and management.
  • Data entry.
  • Data queries and validation.
  • Develop the data management plan.
  • Data quality assurance checks and data lock.

Currently, the preferred EDC platform for study data collection is iMedidata Rave®. 

  • Develop the randomisation method 
  • Develop the randomisation schedule
  • Set up and conduct  User Acceptance Testing (UAT) of study specific randomisation system
  • Treatment emergency unblinding

Currently, the preferred online randomisation services are provided by FormsVision (TENALEA) and SealedEnvelope.

  • Develop the statistical methods.
  • Participant selection and sampling strategies (including power calculations).
  • Develop the statistical analysis plan.
  • Develop randomisation schedule.
  • Conduct central statistical monitoring.
  • Statistical analysis and reporting.
  • Interim analysis.
  • Contribution to final report and/ or publications.
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