Tailored strategies aligning with EU Clinical Trial Regulation.
Comprehensive planning for successful initiation.
Clinical Trial Applications (CTA) Coordination
Meticulous coordination for smooth CTA submissions.
Expertise in managing submissions from Phase I to Phase IV trials.
Coordinates, manages, and prepares CTA submissions for international clinical trials to Regulatory Authorities and Ethics Committees globally, ensuring compliance with EU CTR 536/2014 and
CTIS requirements, as well as local requirements in non-EU countries.
Manages requests for information (RFIs) and regulatory/ethical queries, ensuring timely responses and liaison with internal/external functions, Regulatory Authorities, and Ethics Committees.
Compliance Assurance
Ensuring compliance with EU536/2014 and CTIS requirements, as well as local requirements in non-EU countries.
Providing country-specific adaptations for seamless submissions.
Conducts and/or supervises regulatory procedures during the life-cycle of clinical trials, including substantial modifications, notifications, and periodic reporting.
Ensures submission tracking and follow-up on regulatory submissions.
Provides advice on regulatory documentation development to meet relevant regulatory requirements and comply with departmental and company procedures.
Reviews German country-specific translations of submission documents for the DACH region.
Bid Defense Meetings
Expert representation and insights during bid defense meetings.
Addressing regulatory concerns and providing subject matter expertise.
Global Trial Expertise
Extensive experience in managing submissions for global clinical trials.
Adaptation to various therapeutic areas, including oncology, CNS, and respiratory & infectious diseases.
Manages submissions from monocentric to global clinical trials.
