Pharmaceutical Clinical Trials

CamNtech has extensive experience of supplying both products and services to pharmaceutical clinical trials

Company competencies

• In depth experience of working with pharmaceutical companies and CRO's
• Experienced in working in all phases of clinical trial
• All products are CE marked as medical devices where appropriate
• All products are FDA 510 compliant where appropriate
• Systems can be supplied compliant with CFR 21.11
• Full training and support available

The following products are suitable for use in clinical trials:

Actiheart

Records activity, heart rate and heart rate variability in a small, lightweight and waterproof device which simply clips to two ECG pads on the chest:

• Ideal for measuring HRV data in phase I safety studies
• Ambulatory capture of HRV data in other later phases for up to 3 ½ days
• Can capture AEE data in free living for up to 3 weeks; ideal in intervention studies

PRO-Diary

Electronic wrist worn patient diary for subjective data capture in real time

• Collect subjective patient data in real time
• Know that your data is actually collected at the times required with alarmed prompting
• Configurable in any language so can be used in projects in any country
• Large memory and long battery life mean that data can be captured for up to 1 month in longer studies

Actiwave and Cardio

Modular 1, 2 or 4 channel ECG waveform recording; miniature data loggers which record for up to 24 hours with user selectable bit rates and sampling frequencies

• Small design makes wearing extremely easy as there is no need for a large waist mounted box
• Ideal for use in paediatrics and in veterinary applications
• Designed for use with populations who are unable to cope with larger technology such as patients with Alzheimer's or dementia