Services

Our services

We are a service provider for the pharmaceutical and medical device industry and other research organizations.

 

Our services in detail:

Study Planning and Design
Protocol development for clinical trials and all types of non-interventional studies. Biometric consulting regarding study design, including sample size estimation and randomization. Also for electronic trials (eTrials).

Case Report Forms and Documents (paper-based or electronic)
Concepts and layouts for Case Report Forms (CRF) and any other type of documents for clinical trials. Editorial service, printing and logistics. Concept, rogramming and validation of eCRFs.

Project Management
Study placement, investigator recruitment, CRF-tracking, reporting of adverse events, monitoring , granting of investigators, monthly reporting to the sponsor.

Data Management
Development of data collection guidelines, database specifications and logic checks design.

Performance of CRF-tracking and data clarification tracking, double data entry, coding, automated data clarification forms generation, database editing and quality control reviews.

Taking over electronic data (e.g. from eTrials).

Statistical Analysis
Descriptive analysis of data by generation of tables, graphs and listings. Testing of hypotheses by state-of-the-art methodology. Use of validated software packages (primarily IBM SPSS®, and others).

Statistical estimation of sample size and power calculations.

Methodological & statistical support for reimbursement dossiers
Support on all aspects of statistical analysis required for HTA submissions. E.g.:
• Meeting requirements for a reimbursement dossier submitted
   to IQWiG (Germany)
• Demonstrating clinical effectiveness and added value over the standard care
• Performing indirect treatment comparisons, meta-analysis or
  network meta-analysis.

Pharmacovigilance
Periodic Safety Update Reports (PSUR).
Literature screening for adverse drug reactions.

Medical Writing
• Clinical study reports according to ICH Guideline E3
• Clinical investigation reports for medical devices according to EN ISO 14155
• Clinical evaluation reports for medical devices according to MEDDEV 2.7.1
• Manuscripts for publication including literature research including submission process
• Summary of product characteristics (SPC), package insert, brochures, informed consent forms.

Quality assurance
As an independent external quality assurance unit, we perform many types of audits:
• On-site audits for clinical sites
• Document audits for investigation plans, protocols, CRFs, Informed consent, etc.

Data Management and Statistics

We are providing a competent clinical data management in a timely manner. Conventional (paper-based) or electronically (via an EDC-System). Our services start in the planning phase with the creation of clinical trial protocols or observational study plans and case report forms. Later in entering the data (paper-based) or transferring the data (from EDC) into the analysis database. Including data cleaning. Finally we are analysing your data statistically in order to respond your research questions properly. Results can be presented as Clinical Study or Clinical Investigation Reports, posters or publication manuscripts.

Non-interventional Studies

We are offering a highly efficient full-service for any kind of non-interventional studies (NIS, PASS, PAES):

  • study planning
  • creation of all necessary documents (observational plan, contracts with participating doctors, informed consent, applications to IRBs and authorities, enrollment logs, case report forms (CRFs) including printing and shipping or concept and programming of eCRFs
  • tracking of CRFs or implementation and hosting of an EDC system
  • support for study centers
  • payment of the doctors
  • monthly reporting about all aspects of the study to the sponsor
  • notification of authorities
  • data management and data cleaning
  • check for adverse events including reporting
  • monitoring (if desired)
  • statistical analysis of the data
  • reporting and publication of  the results.

Monitoring

Our clinical monitors assure that your study is being conducted according to your standard operating procedures (SOPs), good clinical practice (GCP) and the acutal legal requirements.

We can assist you in the initiation of clinical studies as well in the conduct of clinical studies. Our clinical monitors check the data „on site“ or „remote“ for completeness and plausiblity and verify them against medical patient records (source data verification).

Based on their data managment background, our monitors are able to detect errors rather early or are able to help to prevent these errors. The „direct link“ to the data management is speeding up the data cleaning process substantially.

Our well-trained and experienced monitors cover not only pivotal clinical trials with drugs and medical devices but monitor also non-intervential studies to assure their quality.