SERVICES

Study Management
Efficient management of clinical trials from planning to completion.

• Planning, organization, and conduct of interventional studies (Phase I–IV)

• Coordination of multicenter and multinational studies

• Budget, timeline, and milestone management

• Document and submission management

Sponsor and Vendor Oversight
Transparent control and supervision of external partners and service providers.

• Feasibility analyses and selection of study sites/service providers

• Support with contracts and budget negotiations

• Development and implementation of oversight plans, including key performance indicators

• Ongoing performance monitoring of external partners

Monitoring (Onsite & Remote)
Ensuring data integrity and compliance throughout the entire study.

• Monitoring according to ICH-GCP and study protocol

• Preparation, conduct, and follow-up of monitoring visits

• Documentation review, follow-up of findings and CAPAs

• Progress reports and status updates

Non-Interventional Studies (NIS)
Regulatory-compliant support for observational and registry studies.

• Planning and coordination of observational and registry studies

• Ensuring legal and ethical requirements

• Data collection concepts, data review, and reporting

Investigator Initiated Studies (IIS)
Professional and organizational support for investigator-led research.

• Support with protocol development and submission documents

• Budget and contract support

• Sponsor oversight in investigator-initiated studies

• Ongoing reporting and documentation management

Quality and Risk Management
Reliable quality assurance and risk management for your study projects.

• Establishment and maintenance of quality management systems (QMS)

• Creation and maintenance of SOPs

• Audits and inspection preparation

• Risk assessment and mitigation planning

Consulting
Expert advice on all aspects of clinical research.

• Consulting on study design, regulatory requirements, and study operations

• Process review and optimization within the study workflow

• Support in selecting and implementing appropriate tools (e.g., eTMF, CTMS)

Recruitment Support for Diverse Study Populations
Targeted measures for the successful inclusion of diverse patient groups.

• Assessment of recruitment feasibility and site-specific potential

• Support in site selection and start-up to enhance recruitment

• Development of factual recruitment strategies in alignment with ethics and sponsor

• Monitoring of recruitment-related metrics and early action planning

• Sensitive consideration of diverse patient groups (e.g., by age, gender, socio-cultural background) within the framework of regulatory requirements

Medical Writing
Professional preparation of study-associated documents and materials.

• Creation and revision of protocols, investigator brochures, informed consent forms, study reports, and regulatory submissions

• Ensuring clarity, consistency, and regulatory compliance across all study documents

• Support with lay summaries, publications, and communication materials

Compliance Note:
All measures are carried out in accordance with ICH-GCP, local regulatory requirements, and GDPR. Recruitment activities are implemented exclusively in ethically approved, compliant formats.