O4 research’s experienced Clinical Research Associates (CRA’s) monitor investigative sites across the UK and Ireland and therefore have an in-depth knowledge of local regulations, practices and cultures. We appreciate that a successful CRA/Site relationship is based on trust, respect, shared goals and objectives and the O4 research management team place great emphasis on training and development of CRAs.
We expend much time and investment in mentoring and developing skills and expertise which enable our CRAs to develop strong dynamic relationships with the investigator site staff. Our CRAs empower and support sites in the development of robust and strategic recruitment strategies whilst providing both motivation and assistance with patient recruitment and retention.
In addition, CRA training includes Good Clinical Practice (ICH GCP), relevant Standard Operating Procedures and study specific technological and medical/therapeutic related training. Each CRA has proven monitoring proficiency and effective communication skills for engaging with the study team and site staff.
From the outset, O4 research prepares a Study Monitoring Plan incorporating all requirements and reporting methods as agreed with the client including expected frequency and conduct of on-site monitoring visits.