Expertise.
Clinical Affairs Consulting.
We support you in the precise planning, regulatory-compliant execution and successful completion of clinical trials.
Precise?
Are your clinical trials optimally tailored to your requirements?
Are you sure?
Do your clinical trials meet all regulatory requirements?
Successful?
Are you optimizing your study processes to achieve market access faster?
Ready to conduct your clinical trials efficiently and successfully?
Clinical Affairs Consulting - Planning and conducting clinical trials.
Our Clinical Affairs Consulting supports you in precisely planning clinical trials and fulfilling regulatory requirements in order to achieve market access efficiently.
Clinical trials are increasingly under regulatory pressure, and success depends largely on precise planning and execution. Our consultants help you to optimize the entire study process - from conception to implementation and follow-up.
Our services include:
- Clinical trial planning: Strategic planning of clinical trials taking into account the requirements of the FDA, EMA and other regulatory authorities
- Regulatory compliance: Ensuring full compliance with regulatory requirements through customized strategies.
- Data management and quality assurance: Implementation of data management and quality assurance systems to ensure the integrity of your study results.
Clinical Affairs Consulting at a glance
Our Clinical Affairs Consulting Services offer you comprehensive support to successfully plan and conduct clinical trials and meet regulatory requirements.
Clinical trial planning & design.
- Optimization of study protocols to increase efficiency
- Strategic design of studies to maximize chances of success
- Consideration of regulatory requirements in study planning
Regulatory compliance & approvals.
- Support in complying with FDA, EMA and global guidelines
- Strategic planning and submission of Clinical Evaluation Reports (CER)
- Ensuring regulatory approval
Data management & quality assurance.
- Introduction of efficient data management systems to optimize study data
- Implementation of quality controls to ensure compliance with the highest standards
- Optimization of traceability and data integrity in all study phases
Successful projects in the field of Clinical Affairs Consulting.
Our Clinical Affairs Consulting case studies show how companies have successfully completed their clinical trials through optimized study protocols, data management and quality assurance.
Optimization of clinical study planning and quality assurance
Data management and patient recruitment in global clinical trials
Regulatory compliance and study protocol optimization
Challenge.
A medical technology company faced the challenge of ensuring regulatory compliance and optimizing inefficient study protocols.
Measures.
- Revision of study protocols to increase efficiency
- Implementation of a system for quality assurance and regulatory compliance
- Development of a risk management system for clinical trials
Results.
- 35% increase in efficiency through optimized study protocols
- Compliance with all regulatory requirements
- Accelerated market approval through improved quality assurance
Success.
The company has successfully optimized protocols and regulatory compliance and accelerated its clinical trials.
Optimize your clinical trial processes with us.
Our Clinical Affairs Consulting Service Portfolio.
Our Clinical Affairs Consulting Service portfolio offers comprehensive solutions for planning, conducting and monitoring clinical trials to meet the highest quality standards and regulatory requirements.
Ensuring full compliance with FDA, EMA and ICH guidelines. We provide strategic advice and support for global approval processes and regulatory submissions.
- Regulatory Support & ICH Compliance: Our experts ensure that your studies comply with current global regulatory requirements at all times. We guide you through all stages of the approval process, including FDA and EMA requirements
- Real-Time Regulatory Updates: Implement a system that ensures you stay on top of the latest regulatory developments
Optimization of study protocols, quality controls and data management systems to ensure compliance with the highest standards and accelerate market access.
- Data analysis and generation: Support in the development of clinical data and real-world evidence to enable lifecycle extensions of your products. We offer workshops on data gap analysis and investigator-sponsored studies
- Digital Innovation in Data Management: Integrating modern technologies to improve data collection, validation and real-time monitoring of your clinical trials
Efficient strategies for patient recruitment and systematic monitoring of studies in real time to optimize study progress.
- Optimized patient recruitment: Improving patient recruitment through tailored strategies that rely on digital innovation and patient-centric approaches
- Stakeholder engagement: Strategically engaging opinion leaders and stakeholders to ensure the success of clinical trials and foster greater collaboration
