Advantages of  Home Care Service

1. It reduces the number of hospital visits dramatically. Advantage for the patient :
Far less demanding for patient and family;
2. It raises inclusion on site by 80% and prevents from premature discontinuation of the
trial (drop-out);
3. High compliance. Fixed team of specialised trial nurses who work uniformly
in accordance with same procedures;
4. Tailor-made appointment: Patient’s diary and protocol visits schedule are
leading;
5. Best possible service for patient;
6. Population for study rises by increase of inclusion;
7. Direct communication between nurse and investigator.

Site Trial Support

CTS places trial nurses and study coordinators in study centres. The research professional performs study-specific tasks for a given period, for a specific trial, to help ease work pressure of the research team, or to offer research expertise.

The research professional or research team may also be deployed for multicentre research,working in different research centres simultaneously.

Main tasks and skills CTS research nurses

What tasks CTS research nurses carry out depends on the particular study. Study-specific tasks are executed according to protocol and the SOP’s or work regulations. Common tasks are: taking and processing blood samples; taking blood pressure; making ECG; administering medication (injection or drip); inquiring after (serious) side effects; filling out (e)CRF and taking questionnaires. Patient safety and the quality of the collected study data are safeguarded by study-specific courses and annual ICH-GCP courses.
CTS research nurses are experienced within the field of medical scientific research (phases 1-4). They have extensive experience in oncology; blood diseases; haemophilia; influenza vaccination studies; cardiology; dermatology; lung diseases; stomach, intestinal and liver diseases; kidney diseases; but also in rare diseases like Prader Willi Syndrome, Duchenne and ALS.

Background

Clinical trials have to be run in accordance with international and local standards, as prescribed in the International Conference on Harmonisation Good Clinical Practice (ICH-GCP), WMO (Medical Research Involving Human Subjects Act) and the European Clinical Trial Directive 2001/20/EC.

Research in accordance with these regulations guarantee the wellbeing, personal rights and safety of the patients, as well as ensuring reliable research data. Hence, all researchers and other participants are required to act according to these regulations.

Accreditation

• Accreditation Bureau Algemene Nascholing (PE-online) for medical specialists;

• V&VN for nursing specialists
• Transcelerate BioPharma
• Recommended by EMWO ( Dutch Examination Committee GCP exam)

At your request, our courses can be accredited for other professional associations.

Tasks and responsibilities of parties involved, according to ICH-GCP regulations

• Preparations
• Selection of research center
• Medical Ethical Committee (Medisch Ethische Toetsingscommissie)
• Initial monitoring visit
• Essential documents
• Reliability of research data
• Selection of patients
• Informing patients
• Visiting patients
• Study-specific measurements
• Monitoring visits
• Verification of source data
• Drug accountability
• Data queries
• Quality control on various levels, among which audit and inspection
• Close-out visits and archiving

Costs and conditions

One-day ICH-GCP training: EUR 495 (excl. 21% VAT)
Two-day ICH-GCP training: EUR 795 (excl. 21% VAT)
Includes use of training facilities, course syllabus, coffee & tea, lunch and snacks. The training requires at least 5 participants to take place. Maximum number of participants: 15.
The cost for in-company training is dependent on the content of the course and the number of participants (min. 5). Please contact us for the possibilities and a quote.
Payment not later than twee weeks before start of training.