Consultation services, clinical
Documentation:
- Preparation of Investigators Brochures (CIB) for new clinical trials Phase I-III.
- Preparation of Confidential Summaries and Product Profiles for partnership, investors and marketing.
- Preparation of Expert Reports.
- Participation in preparation of IND/BLA and NDA/MAA/ATMP files and updates.
- Pharmacovigilance - EudraVigilance Services including safety issue reporting to authorities.
Clinical Studies:
- Participation in preparation or check-up of study plans. Trial monitoring. Study reporting.
Consulting in chemical safety
Chemicals, agrochemicals, food additives, functional foods etc. Please inquire!
Medical Writing Services
Publications, reviews, abstracts, presentations, posters.
Consultation services, preclinical: Consulting Drug Safety
Preclinical safety studies/programme:
- Concerns all formal studies depending on the targeted clinical study phase (I-III), indication, route etc. The studies or the whole safety programme will be tailored so that the documents are ready in time before clinical trial or NDA/MAA application. Also specific studies are/can be included (e.g. ADME, interaction, induction, medical device safety studies).
- After receiving offers from several appropriate CROs the studies will be contracted according to Clients priorities (CRO of best cost/quality, timings, special know-how). Study plans will be optimized, studies will be monitored in life, and interpretations and reports will be optimized. Consultation can be also at any smaller duty level.
Preparation of safety documentation:
- Writing summaries, tabulated summaries, expert reports, development plans and presentations.
Other services
Please inquire for the possibilities to help in any of your problems that may occur!