KTA Support and training provides information, advice and guidance througout the entire study process from planning to reporting.

We offer the following services:

– Writing/editing protocols in accordance with the ICH-GCP guidelines
– Drawing up patient information
– Designing Case Report Forms (CRF)
– Applications to Sweden’s Medical Products Agency via EudraCT
– Providing support for applications to Sweden’s Ethics Review Board
– Producing forms for mandatory clinical trial documentation
– Randomising clinical trials
– Holding kick-off meetings with the clinical trial team
– Reporting Adverse Events
– Monitoring compliance with requirements during clinical trials
– Writing/editing final reports in accordance with the ICH-GCP guidelines.

We conduct training and education according to our client wishes

Please contact us to discuss your specific requirements.