In co-operation with
Our services
A big network of Clinical Research Professionals (D, A, CH, NL, BL, F) and contractual cooperation with SZB (Study Center) facilitate comprehensive support for your study project and cops multiple indicators of drug trials, Medical Device- and Non- Interventional studies. The performance comprises:
- Monitoring Support through an extensive network of quickly available, experienced CRA’s
- Monitoring of clinical studies from Phase I till IV in all indication areas after GCP and ICH
- Pharmaceutical studies
- Medical-technical studies
- Non-interventional studies
- Medical and scientific planning of the study
- Development of project planning, determination of a collective
- Determination of Responsibility Split
- Planning of logistics (samples, IMP, etc.)
- Obtaining and evaluation of cost offers (CRO / other serviceproviders)
- Vendor-Assessment pursuant ICH GCP
- Preparation and review of test plan
- Preparation, translation and review of patient information and consent form
- Creation of other study materials (e.g. patient ID card, smock bags info)
- Creation of other manuals (Labor-Manual, etc.)
- obtaining, tracking, review and approval of Site Essential Documents
- creation of advertising tactics with help from the media center of the University of Bonn and the university hospital
- Coordination and control of all functional units of the study (incl. Monitoring/ Safety-Management/ Data Management/ ext. service providers, CRO /pharmacy etc.)
- Coordination of project communication and control of project running (and others as to SOPs, GCP and deadlines)
- Analysis of project status; development of status reports
- Coordination of study medication
- Practical execution of randomization
- Budget supervision
- Regular contact with testing center (telephone, e-mail, fax)
- Transport of study materials
- Installation and care of Trial Master File (TMF)
- Preparation of Investigator Site File (ISF), incl. instruction
- Creation of study specific logs, forms etc.
- Support contract management:
- adoption of sponsor function
- with money lender study
- with testing center
- with service providers (CRO, labor, pharmacy)
- Execution of insurances (clinical trials insurances, way-to- work accident insurances)
- Communication with insurances during the study progress
- Execution of feasibility
- Development of questionnaires
- First contact to the center
- Arrangement of confidentiality
- Traceability of documentation
- Communication with the sponsor, Evaluation of feasibility
- Filing at authorities/ ethics committee (preparation,
performance, processing of defects) at:
- Higher federal authorities (BOB (BfArM, PEI, BfS)
- Responsible ethics committee
- Involved ethics committee(s)
- Authority submission according to § 67
- Display at the local medicines commission
- processing Amendment (changes of documents; approval procedures EK and BOB; display according to §67; updating the documents of the center)
- Sign out of the study at EK, BOB and regional authorities
- CRF development and review (incl. creation of CRF-fill in instruction)
- Test with CRFs with trial patients for plausibility (Dummy Patients)
- Compilation of CRF-folders
- Creation of a patient diary
- Questionnaires (obtaining licenses)
- Creation of Data-Management Strategy
- creation of study documents as Data Management Plan (DMP) and Data Validation Plan
- TMF-care
- CRF-Tracking
- Study execution paper based (DDE) and electronic (EDC)
inserted Clinical Data Management Systems:
- XClinical MARVIN (EDC and DDE)
- RedCAP (only DDE with non-AMG/non- MPG Studies)
- In-house Data collection (DDE) database Set-Up and Validation
- Query preparation and Query management
- Coding (Coding AEs according to MedDRA)
- Data import Data export creation of reports
- User-Administration (Service) EDC
- IWRS (interactive web response system)
- Database-Reconciliation
- CP-Audits
- Vendor-Assessments
- Planning of quality control in study projects
- Biometric planning and design of the study
- Planning of number of cases
- Creation of „biometric“ parts of the study protocol
- Creation and review Statistical Analysis Plan
- Collaboration in DSMBs
- Development of randomization plans
- Planning and execution of interim evaluation
- Statistic evaluation
- Development of a biometric final report
