Clinical Trial Experts

Our services

A big network of Clinical Research Professionals (D, A, CH, NL, BL, F) facilitate comprehensive support for your study project and cops multiple indicators of drug trials, Medical Device- and Non- Interventional studies. The performance comprises:

Clinical Monitoring

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

Project planning

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

Project coordination ( run phase)

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 TMF / ISF

Installation and care of Trial Master File (TMF)
Preparation of Investigator Site File (ISF), incl. instruction
Creation of study specific logs, forms etc.

Contract management

Support contract management:

adoption of sponsor function
with money lender study
with testing center
with service providers (CRO, labor, pharmacy)

Clinical trials insurance

Execution of insurances (clinical trials insurances, way-to- work accident insurances)
Communication with insurances during the study progress

Selection of suitable testing centers (Feasibility)

Execution of feasibility
Development of questionnaires
First contact to the center
Arrangement of confidentiality
Traceability of documentation
Communication with the sponsor, Evaluation of feasibility

Permission and reporting procedure

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

Data management and Patient documentation form (pCRF)

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)

Data management (eCRF)

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