Our services include, but are not limited to:-
- Do-ability/Feasibility
Oncrodex can conduct simple top-line do-ability/feasibility assessments for early phase Oncology trials, as an initial step towards considering where and how to conduct your Clinical Research project.
- Medical Writing and Document QC
Preparation or review of Patient centric documentation packs required for clinical trials, e.g.
a. Summary Patient Information Sheets
b. Patient Information Sheets and Consent Forms
c. GP letters/Diary Cards/Contact Cards etc
We may also be able to assist you with preparation of other study documentation, such as various Study Reference Manuals/ Study Plans or document QC
- Ethics Submissions
Oncrodex can assemble your Ethics Submission Pack, complete and submit ethics applications, prepare documentation, identify and book the Ethics Committee meetings
- SOPs
Oncrodex can assist you with writing and drawing up specific Clinical Operations SOPs and processes in order to maintain ICH GCP compliance.
- Resource Solutions
Oncrodex can provide short term Monitoring or Project Management additional resource for specific study related tasks i.e. to deal with a backlog of data, provide additional support to meet study deadlines, audit preparation or troubleshooting assessment and solution management.
- Visit Report Review
Oncrodex can offer Site Visit Report review, feedback and escalation services from Pre-study visits, Initiation, Monitoring to Close out.
- Audits and Inspection Readiness Preparation
Oncrodex can undertake Trial Master file review to facilitate inspection readiness
- Consultancy Services
Oncrodex can offer unique and niche experience in setting up, running and managing Phase I Oncology trials providing a wide range of consultancy and oversight solutions
If you don’t see a service listed here, that you may be interested in, we work with a number of providers and freelance clinical research professionals specialising in Oncology and we may be able to help. Please get in touch to discuss your requirements.