Services for Businesspartner

• Preparation of study protocols and all associated documents (e.g., informed consent forms)
• Conception and development of study concepts and protocols for investigator-initiated studies in which GBG acts as the sponsor
• Medical monitoring of clinical data (e.g., laboratory values, identification of outliers)
• Preparation of reports on SUSARs and/or SAEs
• Pharmacovigilance activities (review and evaluation of SAEs and SUSARs, preparation of DSURs)
• Preparation of clinical study reports (CSRs)
• Evaluation of reference documents (e.g., Investigator’s Brochure)
• Participation in the planning and execution of data analyses
• Support with medical coding (e.g., WHO, MedDRA, ICD)
• Active preparation for and participation in sub-board meetings with the GBG KOL network
• Organization of workshops for investigators (e.g., presentation of new projects, active ingredients, management of adverse events)

+ Additional service:

• Submissions to the EMA and ClinicalTrials.gov upon study completion
• Publication of clinical studies in renowned journals through:
• Coordination of the annual publication strategy
• Presentations at international conferences
• Publication of manuscripts in renowned international journals
• Communication with numerous international stakeholders (authors, collaborating partners, and pharmaceutical partners)

• Strong Project Management Team
• A large team of project managers with experience in oncology research supports projects in all phases, from Phase I to Phase IV.
• Close Relationships with Study Sites
• Thanks to GBG’s close relationships with study sites, our project managers ensure a quick and smooth start to drive and secure patient recruitment.
• Central Point of Contact for the Study
• Coordination of internal teams to ensure successful execution and seamless communication among all stakeholders.
• Global Coverage
• GBG’s core project management team is based in Germany. Thanks to strong global partnerships, we can successfully manage large Phase Ib through IV studies.
• Partnership-oriented approach
• Our teams act as partners to our sponsors and support study conduct on an equal footing.
• Operational backbone
• Full operational oversight throughout the entire project. Proactive risk management from the outset to ensure smooth study progression.

• Close collaboration with GBGs study sites – selecting the right sites from the start
• CDAs and MSAs signed with the majority of study sites
• Utilization of fast-track sites to achieve a turnaround time of 2–6 weeks for document collection and contract signing with the sites
• Experienced regulatory team to support submissions in EU and non-EU countries
• Close collaboration with international study groups to shorten start-up times
• Excellent project management team to support sites

Finding the right center for your project

• Extensive database of investigators and study centers
• Existing CDAs and MSAs with many of our GBG network centers
• Close collaboration through subcommittees, workshops, ASM, etc.
• Clear understanding of the situation at the study sites

Selection of suitable sites from the outset to minimize the number of sites without recruitment

• Careful review of feasibility results
• Sites with Fast-Track status / Priority 1
• Existing MSA + rapid ramp-up + good recruiters + no PSSV required + suitable patient pool
• Priority 2 sites
• Existing relationships / MSA + good recruiters + suitable patient pool
• Final decision in close collaboration with the sponsor

Regulatory expertise

• Submission to ethics committees and authorities (BfArM & PEI)
• Voluntary Harmonization Procedure (VHP)
• CTIS (Part I and Part II)
• IVDR
• MDR
• International experience outside the EU

Ensuring high data quality from clinical trial sites

• Strong monitoring team with scientific and medical backgrounds
• Support for on-site and remote monitoring visits
• Coverage from Phase Ib to IV
• Risk-based monitoring
• Targeted and event-driven monitoring plans
• Close relationships with investigators at study sites

National and international experience – support for small to large pharmaceutical and biotech companies

Standard services:

• Coverage of all aspects of clinical monitoring visits
• Experience in drug accountability in open-label and blinded studies, regardless of the route of administration

Additional services:

• Support for sponsor audits
• Support for regulatory inspections
• Close collaboration with participating hospital pharmacies
• Up-to-date in accordance with ICH GCP E6/R3

• Protocol review
• Patient profiles
• CRF design
• Setup and maintenance of the EDC system
• Edit checks/data validation
• User management
• Data entry guidelines
• Training
• Data cleansing/queries
• SAE/AE reconciliation
• Reporting
• Documentation overviews
• Department-specific tools
• Central database
• Archiving

• Statistical design of clinical trials (sample size, endpoints, alpha level, randomization, stratification)
• Interim and final analyses to ensure scientific validity
• Support for independent data monitoring committees
• PRO/QoL analyses
• Support for publications and regulatory submissions
• Contribution to translational research through biostatistical modeling
• PK/PD analyses
• Pooled and meta-analyses
• Bayesian methodology
• Systems: SAS, R (analysis), EAST, nQuery Advisor (sample size)

• Preparation and review of protocols in accordance with international standards
• Preparation of study reports
• Support with manuscripts and publications
• Posters
• Organization of workshops
• Conference presentations
• Literature review and knowledge translation
• Training and continuing education materials

• Controlled Documents
• Development and Monitoring of Training Programs
• Quality Management System
• Supplier Qualification
• Audits and Inspections
• Management of Corrective and Preventive Actions (CAPA)
• Support for the Validation of Internal Systems
• Risk Management
• Point of Contact for All Questions Regarding Quality Management
• Management Report
• Internal and External Inspections

• Extensive biobank and cryobank resources for biomarker projects
• Sample tracking and data management, data reconciliation
• Labkit management, assembly, and distribution
• Logistics for biosamples, nationally and internationally
• On-site support and training, sample management guidelines, laboratory manual
• Reporting and communication, sample status reports, planning of biomarker analysis
• Coordination of translational research projects, processing of sample requests
• Compliance with legal and ethical regulations regarding the collection of biological samples

Long-term storage of various biomaterials from clinical trials:

• Whole blood
• Plasma
• Serum
• Urine
• Feces
• Fresh-frozen tissue
• DTCs from bone marrow (disseminated tumor cells)