contract Development services
Activaero does not just provide off-the-shelf systems for partners. The Company works with partners to design and develop systems tailored to the partner, the therapeutic and the clinical trial.
Activaero can provide the following consultancy and services to partners looking for a device to use in clinical trials:
- Design input
- Prototype development
- Transition to manufacturing and performance testing
- Regulatory compliance
Activaero has both a design and a manufacturing capability inhouse at its headquarters in Gemünden. The facility is development certified according to ISO 13485:2003 and ISO 9001:2000 and Activaero has the following capabilities, know-how and expertise:
- Construction: CAD-Workstations (Solid Works)
- Electronic development (microprocessors,..)
- Software development
- Aerosol Technology (fluid mechanics)
- User interfaces (multilingual)
- Flow control systems
- Pressure transducers
- Gas humidification
- Data communication
- Desktop software development for data evaluation for physicians
- Central database software development
If you would be interested in finding out more contact us here.
Clinical Trial logistics
Activaero works with partners to coordinate the logistics of trials using its technologies. In particular, Activaero can offer the following support to partners conducting clinical trials with its technologies.
- Logistics for the manufacture and distribution of AKITA® and Watchhaler™
- Design modification and manufacture of of AKITA²®
- Logistics Services for national and international Clinical Trials:
- Internal project initiation
- SMC Device configuration
- Manuals, forms and checklists
- Internal process training
- Training of study centers
- Shipment collection
- Compliance
- Individualisation and shipment of Smart Cards
- Customs handling
- Support and advice
- Service and Repair
- Device Replacement within 24/48 hours in the EU
In particular, for those partners using our devices with smart cards (AKITA and AKITA²®), Activaero supports the programming and recording of data on these cards to ensure that patient breathing patterns and trial parameters are recorded for use in the trial. This can all be accomplished electronically using the card reader attached to a computer at the study center. The patient lung function data is recorded on the card. The software supporting the card then sends the encrypted data via the WWW to Activaero where it is processed and returned to the study center where the patient-individual breathing pattern is recorded on the card for use with that patient in the trial.
Activaero also works with its sister company, Inamed Research, a CRO specializing in trials of inhaled medications, in the conduct and logistics of national and international clinical trials of inhaled products.
If you would be interested in finding out more contact us here.