We provide an à la carte service, customized to your exact requirements. Services include, but are not limited to:
- Evaluation of equipment suitability
- Purchasing & order tracking
- Class III device chain-of-custody & storage
- Equipment rental
- Manufacturer/Supplier liaison
- Review of regulatory considerations
- Study kit design
- IRB/EC liaison
- Translations management
- Study kit fulfilment
- Provision of supplies throughout the study
- Contact Center – phone, email, chat
- Predicate (device comparator) sourcing
- Equipment recovery
- Training & collateral materials
- Meeting presentations
An example of how we add value:
A clinical trial requires blood pressure monitors to be sent to 30 sites in three countries. Some sites need two monitors, some need one. One or two may need more, but you won’t know that until a year into the trial. Not only are the regular monitors required, but each site must also get an additional extra large cuff, a supply of batteries and a tape measure. The manufacturers packaging must be discarded, and trial-specific documentation developed, printed and sent with the equipment. To round it off, all of this needs to go in a practical and protective carrier, clearly marked with the study identification information.
This is not where the story ends. The sites need to be trained on the use of the equipment; PowerPoint presentations are required for the Investigator Meeting, and other training materials developed. The clinical sites also need a competent point of contact for equipment support – not the manufacturer, who knows nothing of the protocol demands, nor the project manager, who is focusing on a thousand “more important” issues.
This is a typical example of a small work scope that presents problems for Clinical Trial Managers. It is not big enough to captivate the interest of the large core laboratories or equipment supply companies, nor is it interesting to the multi-million unit equipment manufacturer – so it ends up being carried out by somebody who doesn’t have the processes to handle it properly, and this small clinical trial requirement soon becomes a big headache.
