Managing clinical trials
Clinical trials generate data to prove product effectiveness and enable you to validate product claims. There are large organisations who can run the trial for you, but, as you hand your study to them, you lose control of the process and timescales, leading to delayed product launch and subsequent sales. Using a freelance clinical trial manager, who becomes part of your company for the duration of the clinical trial, allows you to manage objectives and timescales to keep costs to a minimum.
I have the experience and skills to manage the clinical trial process from start to finish, which will allow your existing employees to continue to do their work in scaling up manufacturing and preparing for launch.
Responsibility for the trial process includes:
As a freelancer I can embed in your organisation, taking on a company identity for the duration of the trial. This helps to raise your profile with customers, and has the potential to feed in to sales from trial sites when the study is complete.
Please contact me to discuss your needs and deadlines. In pre-Covid 19 times I would have met you for a face to face discussion, but whilst we are still expected to maintain a social distance I am happy to talk via video conference.
© R Howell
I have the experience and skills to manage the clinical trial process from start to finish, which will allow your existing employees to continue to do their work in scaling up manufacturing and preparing for launch.
Responsibility for the trial process includes:
- Preparation of all documents, protocol, investigators brochure, patient leaflets, consent forms, site files
- Application for regulatory permission through MHRA, Health Research Authority (HRA) and Research Ethics Committee (REC) portals
- Site recruitment and NHS contract process, in primary and secondary care
- Training for all healthcare professionals at the start of the fieldwork
- Liaison with healthcare professionals to ensure subject recruitment is to target
- Transcription of data gathered to allow statistical analysis
- Regular progress updates for all concerned
- Final report writing
As a freelancer I can embed in your organisation, taking on a company identity for the duration of the trial. This helps to raise your profile with customers, and has the potential to feed in to sales from trial sites when the study is complete.
Please contact me to discuss your needs and deadlines. In pre-Covid 19 times I would have met you for a face to face discussion, but whilst we are still expected to maintain a social distance I am happy to talk via video conference.
© R Howell