We support drug development through clinical research, focusing on oncology, and respiratory and infectious diseases.
With cross-disciplinary expertise, state-of-the-art facilities and far-reaching recruitment capabilities, we can safely shorten the time to market and realize the true potential of innovative drug compounds around the world.
This five minute case study shows how we were able to successfully complete the enrollment process for a phase II clinical trial in asthma patients. The trial studied the effects of a combination of beclomethasone and formoterol on bronchodilation and lung function, comparing administration via a powdered dry inhalator (PDI) with administration via a pressurized metered dose inhalator (pMDI).
To obtain the necessary data, the trial required approximately 60 asthma patients with partially controlled or uncontrolled asthma. Patients had to be enrolled within a short time.
Initially, 204 patients were screened. 144 patients failed the screening, leaving 60 patients for randomization. Two patients dropped out leaving 58 to complete the study. To complete the recruitment process quickly, SGS:
- Closely monitored enrollment from the beginning of the process through follow-up
- Ensured that the right sites were selected
- Installed identical equipment at each site
- Trained staff at each site
As a result of SGS’s excellent project management skills and extensive experience with asthma studies involving inhalators, screening and inclusion took place in only four months. Speedy enrollment contributed to high quality results.
This is the third in a series of case studies demonstrating how we use our scientific and technical expertise and extensive resources to support clinical research and drug development.
Find out more about SGS respiratory diseases services.
Read about an infectious diseases clinical trial.
Read about an oncology clinical trial.