Clinical Trial Documentation Development.
What is Clinical Trial Documentation?
Clinical Trial Documentation refers to the various documents required to design, allow, execute and assess a Clinical Trial.
Throughout the clinical stages of a medicinal product, these and other documents need to tell a consistent story based on the trial data to be successful and progress to Marketing Authorization, requiring extensive trial experience, expertise and planning.
Typically, the essential documents involved are:
- Investigator’s Brochure (IB) – pre-clinical and clinical information.
- Clinical Study Protocol – instructions, objectives and guidelines for all.
- Subject Information and Informed Consent Form – ensures subjects understand the relevant aspects of the study before voluntary confirmation of participation by a subject.
- Clinical Study Reports – interim and final reports during and on completion of the trial.
- Case Record Form (CRF) – records all the various data related to an individual trial subject, including patient trial ID, demographic information, prior health and treatment, inclusion/exclusion criteria, dosage, adverse effects, examinations and conclusion.
Why you should choose Arriello to review your Clinical Trial Documentation.
Our experts understand the criticality of having a thorough protocol prior to study initiation, and we can advise you on the best approach to set-up the safety sections during protocol writing.
In addition to your protocol, our clinical safety consultants can provide a full review of your Reference Safety information, clinical/final study reports, and other documents.
Selected PV Case Studies.
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What our clients say about us.
Working with the Arriello Clinical Safety Team has resulted in flawless forethought, planning and execution. Their global regulatory expertise, coupled with their quality acumen, sets a standard for which other PV service providers should aspire. Nothing has fallen through the cracks and I can sleep at night knowing we are not only operationally prepared, but inspection-ready – a comfort for which I would happily pay multiples.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
My experience with Arriello was an overwhelmingly positive one. Very professional, accommodating and readily able to adapt to our needs even as they changed.