Your partner for
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Scientific support and consultancy
Clinical development | Product optimisation | Scientific Advice Meetings
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Medical Writing
Clinical and Regulatory Writing | Scientific communication
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Project Management & Regulatory
Core document development | CTIS submission | Coordination & supervision
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Monitoring
Risk-based monitoring |
centralised monitoring
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Early-Phase Experts
- First-in-human
- PK & PD
- DDI
- various dosage forms & sites of absorption
- healthy volunteers
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Phase III & IV expertise
- Efficacy trials & non-
interventional studies
- full service or modular
- referral network
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Biometrics & Statistics
- Pharmacokinetic and Statistical Study Planning
- SAP Generation
- WinNonLin / SAS-based programming
- CDISC Submission Package (SDTM/ADaM)
- Compliance to CFR 21 Part 11 and GAMP-5
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EDC and CDM
EDC Services
- Efficient and Customised
Data Capture Concepts
- User-friendly and
cyber-secure eCRF
- BYOD eDiary/ePRO
Clinical Data Management
- Comprehensive CDM Services,
incl. Data Safety Boards
- Smooth and Efficient
Data Processing
- Regulatory Compliance and
Data Integrity
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Pharmaco-
vigilance
- Global Pharmacovigilance Services
- Benefit-Risk Management
- Signal Management and Safety Reporting
- Legally required
responsible persons,
such as:
- EU-QPPV
- UK-QPPV
- Graduated Plan Officer (Stufenplanbeauftragter)
- Safety Officer for Medical Devices
- Drug Safety Officer for Clinical Trials
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