Non-Industry sponsored Clinical Trial Solutions
At Clinexa, we understand that while non-industry funded clinical trials need to be conducted with adherence to the highest standards of quality, delivery and regulatory compliance, the CRO services must be affordable and meaningful. We partner with individual physician investigators, academic and research institutions and other non-industry stakeholders to create and deploy clinical trial solutions that are highly customized and unique to each situation.
At Clinexa, we have deep expertise in supporting end-to-end delivery of Investigator Initiated Trials (IITs). Our experts bring valuable insights at every stage of the process.
Contact us through the form below and one of our experts will be in touch with you right away.
Following is a list of solutions that we provide to non-industry sponsors of clinical trials:
– Literature review
– Study design
– Development of clinical protocol
– Preparation of essential documents
– Regulatory support and guidance
– Preparation of regulatory paperwork
– eCRF design and build
– Investigator Selection and Qualification
– Investigator Site staff training
– SOP development for Investigator site
– Laboratory selection, qualification, and training
– IMP handling and storage
– Study monitoring and project management
– Medical safety monitoring, DSMB
– Pharmacovigilance
– Patient e-Diary
– Data management
– Clinical Study Report writing
– Manuscript writing and publication support
– Biological Sample storage and retrieval
– Audits and compliance support