COA Training

Advancing the reliability of your key endpoints with expertise and precise training

With extensive experience in rare disease clinical development Orphan Reach are pleased to introduce an additional service: Clinical Outcome Assessment Training. Orphan Reach are well equipped to offer solutions related to rare disease protocols, understanding first hand through vast experience in the rare disease clinical space the importance of accurate clinical outcome assessments as a contributing factor for consistency in data collection and endpoint measurement. Clinical outcome assessments and outcome parameters are integral to a trial’s success and therefore ensuring the accuracy of the assessment process is vital to the overall trial outcome. There is no doubt that the data from your trial will not only be more reliable, but also more consistent and accurate if your raters are trained to a collective standard. Reduced inter/ intra rater variability can be achieved whilst providing a service which comes highly recommended by regulatory agencies.

Why is COA training needed?

Without training, results can vary according to the instructions or the training given to the interviewer, or people supervising the PRO data collection
Without training, data can be influenced by human choices, judgement, or motivation.
There can be wide disparities in how the rater’s judgment affects the final rating which can damage the COA’s validity or decrease its reliability.
Clinical trials involving multiple countries and sites face challenges around languages and cultures, creating higher chances of inaccurate data reporting in the COAs, leading to high variability and less reliability in data. These issues can be addressed with COA training.

What are the regulatory recommendations?

The assessment should be conducted and reported by a trained health care professional.
The evaluator requires specialized professional training to evaluate the patient’s health status.
Some training and quality assurance is needed in almost every situation

With Orphan Reach’s COA Training you can be assured that all regulatory recommendations are taken into account to collect data with high reliability.

Orphan Reach has experience in the following outcome measures and function tests:

Orphan Reach’s COA Training is an adaptable service, which can cater to the requirements of any rare disease trial, making it a viable service in any trial setting. If you would like to talk in more detail about your specific requirements please get in touch via our contact page by clicking below.