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Observational Study - Contraceptives

We recruit physicians and patients to participate in large, prospective non-interventional/observational cohort studies.

Challenge: Our client was required to conduct an EMA required phase 4 non-interventional study with a cohort of female patients newly prescribed a particular type of contraception method and a control cohort of patients on Combined Oral Contraceptives. We have been given a period of 2 years to recruit 13,000 females in the UK and 4,000 in France and each patient will receive up to 10 follow ups over a period of 8 years.

Process: Observational studies involve observing patients within routine clinical practices. This project was a prospective cohort study conducted to a strict protocol and which was granted ethical committee approval. The study involved the physician and patient both completing a baseline questionnaire within 14 days of the first prescription, with the patients then followed up every 6-12 months for 8 years.

Outcome: To date we have recruited 4,406 UK respondents and 1,057 French ones and are ahead of target to deliver the full sample within the study timelines.

Feedback: Originally this was to be a UK only project for us but based on our success in the UK our client approached us to see if we could help in France too where they were facing a recruitment challenge. Our client is very pleased with the numbers of patients recruited and the way the project is being managed in both the UK and France.

To download the case study please click on the link : Oral Contraceptives