Clinical Operations
QPS Clinical Operations supports drug development in every clinical stage with a strong focus on Phase II-IV clinical trials and medical device studies.
QPS ClinOps offices are located in the USA. Austria, Croatia, Czech Republic, Germany, India, Netherlands, Spain, and Taiwan.
We conduct and manage clinical studies in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards and all applicable regulatory requirements to pharmaceutical and scientific clients.
Proven Success in Clinical Trial Project Management
QPS will meticulously manage your late phase II-IV clinical research from start to finish.
Our project management services include:
- Coordinates full range of clinical development services.
- Continuous monitoring of study progress (timelines, budget, quality, organization and communication) and optimization where possible.
- Development of a study protocol according to ICH GCP and local requirements/optimization of your study design.
- Development of all essential study documents.
- Regulatory Affairs (strategic development plan)
- Timely submissions to regulatory authorities and ethics committees.
- Selection, set-up and initiation of your study sites.
- Organization and conduct of successful investigator meetings.
- Set up and maintenance of your Trial Master File.
- Closure of clinical trial.
- Coordinating statistical analysis and reporting of your data.
- Archiving of your study files and samples.
- Individual consultancy and support in any other study related issues.
Effective Clinical Trial Site Monitoring & Management
Proper site management is an essential element of clinical trial execution and in ensuring trial success.
Our site monitoring and management services include:
- Monitoring of trial(s).
- Source data verification partial or complete, as required.
- Clinical research associate (CRA) as main contact person for Principal Investigator (PI) and study team.
- Permanent interaction from site selection until closure of a site.
- Ongoing quality control at the site.
- Discussion of recruitment strategies with the study site.
- Set up and maintenance of your trial master file and investigator site file.
- Overview of patient recruitment progress and site performance.
- Discussion of recruitment strategies.
Pharmacovigilance for Your Clinical Trials
At QPS, we have systems in place to enable the identification, recording, reporting and analysis of safety information so that any safety signals that arise during a trial are quickly identified and acted upon.
Our safety reporting and pharmacovigilance services include:
- Creation of safety management plans.
- Development of your safety database.
- Safety reporting both electronically and on paper.
- Maintenance of safety databases for your studies.
- Medical Monitoring
- Complete safety management of your clinical study including medical review.
Data Management for Successful Clinical Trials
Data management is a fundamental element of a successful trial. This step is critical to your success.
QPS data management services include:
- Development of data management plans, data validation plans and data entry instructions based on your specific study design.
- Design of clinical database for clinical and external study data.
- Providing ready-to use forms.
- Providing training and 24/7 helpdesk.
- Data entry and validation.
- Data Coding
- Efficient and compliant data management throughout the conduct of the study.
- Data checks for consistency, validity and plausibility.
- Creation, assignment and maintenance of user accounts.
- Data extracts for further processing by the statistician.
- Compliance Outputs
- Consultancy and support in study design.
- Advice in study planning / sample size calculation.
- Development of the statistical analysis plan.
- Creation and development of randomization schedules, web-based randomization.
- Statistical programming with state-of-the-art software (SAS version 9.3).
- Interpretation, conclusion and reporting of data from a statistical perspective.
- Presentation of results (Interim Study Reports / Statistical Analysis Report).
- Publication and Presentation Material
Medical Writing that Supports Regulatory Success
High-quality medical writing is important to the regulatory success of our clients. Our medical writing writers have the therapeutic expertise necessary to deliver high-quality written material.
Our medical writing services include:
- Development of a study protocol according to ICH GCP and local requirements/optimization of your study design.
- Development of patient information and informed consent.
- Development of other essential study documents (e.g. Investigator Brochures, amendments, advertisements for subject recruitment).
- Certified Translations
- Publication and Presentation Material
- Presentation of results.
Imaging Analysis Aligned with Regulator Expectations
Imaging in clinical trials is on the rise as regulators are increasingly asking for imaging analysis when evaluating clinical trial data.
Our image analysis services included:
- Site Selection and Qualification
- Image Quality Control
- Central Reading
- Quantitative Image Analysis
- Data Management and Statistics
- Fully Integrated Quality System
