Project Implementation, Phase I/IIa
Can we provide active support for your project? If so, this is what you can expect from us:
Order Acceptance
Your first phone call or meeting with us will involve a consultation with our experienced project management staff and will be swiftly followed by a written offer. Feasibility studies are available upon request.
Preparation
Once the contract has been signed, your project is handed over to our study team (comprising a project manager, trial physician, internal study monitor, and administrative and operative study nurses). The following steps are undertaken:
- Protocol creation/ subject information and informend consent
(collaboration between project manager and physician) - Input of know-how; review of protocols and subject information and informend consent
- CRF creation / review
- Notification of regulatory authorities
(Ethics commissions, BfArM [German Federal Institute for Drugs and Medical Devices], RP [regional government offices], Bundesopiumstelle [German Federal Narcotics Control Board]) - Volunteer / patient recruitment
- Additional recruitment phase to take into account any specific volunteer requirements
Clinical Trials
- Outpatient and inpatient studies (long-term studies possible) for all indication areas, e.g. bioavailability, bioequivalence, first in man, drug/drug interaction, drug/food interaction, dose escalation
- Manufacturin licence / GMP area
- Application: p.o. / s.c. / i.m. / i.v.
- Profound experience in testing transdermal systems (TDS)
- Integration of external partners: lab, analysis, data management, specialist medical practitioners, e.g. ENT, x-rays, gynaecological examinations
- Internal monitoring: 100 % source data verification
(this drastically reduces your monitoring expenditure) - Data documentation: paper CRF, eCRF, digital pen, etc
We provide the following services, either in-house or in collaboration with external partners:
- Biometry
- Medical writing
- Analysis