Expert MDR Consulting Services for Clinical Trials

Professional Consulting services for stakeholders of Clinical Trials
Welcome to my consulting services, where I focus on fostering collaboration and partnerships with clinical trial stakeholders.  I am a holder of B.Sc. in Nursing as well as bachelor’s in law and Diploma in Legal practice. Both disciplines are a fundamental part of who Iam as a person as well as a professional.

 

Why Choose Me?

  • Collaboration: I work closely with your team, ensuring aligned goals and effective teamwork.
  • Partnership: I build strong partnerships, providing consistent support and expertise.
  • Shared Vision: I am dedicated to achieving your vision, ensuring regulatory compliance and clinical excellence.

For HR Companies Specializing in Clinical Trials

With a robust background in both legal and nursing fields, I offer a high level of proficiency in collaborating with HR professionals who specialize in clinical trials. My significant insight into the regulatory framework governing clinical studies enables me to provide strategic guidance and practical solutions. I excel in managing proof-of-concept studies and decentralized clinical trials, and I thrive in environments that emphasize innovation, continuous learning, and development.

As an advisor, confidant, and mentor, I make significant contributions to enhancing your organization’s brand. My dedication to staying current with industry trends and regulations—particularly in Software as a Medical Device (SaMD) and Medical Device Regulations (MDR 2017/745)—ensures that I bring advanced expertise to your team.

Key Benefits:

  • Collaborative approach
  • Advanced clinical and regulatory proficiency
  • Effective team navigation
  • Focused on trial efficiency

For Contract Research Organizations (CRO)

My passion for learning and development, combined with my proficiency in supporting clinical trial teams, allows me to navigate the complexities of research with a keen eye for detail and risk-based thinking. I am dedicated to ensuring your learning and development teams are well-prepared for trial management challenges.

I excel in integrating into cross-functional teams and developing robust processes that enhance trial efficiency. My advanced clinical and regulatory proficiency provides valuable insights and tailored solutions to support your objectives.

Key Benefits:

  • Advanced experience in clinical and regulatory environments
  • Seamless integration into cross-functional teams
  • Strong commitment to trial success
  • Expertise in developing and implementing effective processes
  • Ability to provide tailored insights and solutions

For Sponsors of Clinical Trials

Are you working on a study and are you looking for a profile that fits into your study team? Are you looking for a profile that has invaluable insight into the regulatory framework governing studies e.g. Good Clinical Practice (GCP), Good documentation practice (GDP), just to mention but a few. Then I might be the person you are looking for, given my experience as a study team member.
In this role I have acquired and developed key skills such as stakeholder relations, risk-based thinking, managing continuous learning and development and application of lessons learned therefrom, into the study, are but a few of the skills I will boost your team with.
Key Benefits:
Effective team navigation
Focused on enhancing the voice of the patient
Empowerment of trial participants
Clinical governance

Contact Me

Ready to take your clinical trials to the next level? Contact me today to learn more about how my expert consulting services can support your projects.