I support you in 
setting up and developing your clinical research organization through structuring the department and processes 
as well as providing training. 
I also support you in 
planning and implementing your clinical studies.

Jessica Cordes

Where are you currently?

I can help you

  • defining the organizaitonal structure
  • preparing job descriptions
  • hiring and onboarding GCP experienced people
  • supporting and overseeing your Clinical Research team
  • defining a GCP compliant strategy for your Clinical Research activities
  • preparing templates
  • providing vendor governance

I can help you

  • defining your clinical trial design
  • defining your drug development plan
  • considering operational specifications of ATMPs
  • complying to ATMP specific guidelines

Get in touch with me for             live training (online or in-person).

 

I can help you

  • assessing your inspection readiness
  • preparing / revising your Standard Operating Procedures (SOPs)
  • improving your GCP relevant processes and templates

I can help you

  • preparing an action plan for all required tasks
  • selecting your sites
  • selecting your service providers (i.e. Contract Research Organizations, Laboratories, System Providers, etc)
  • negotiating agreements with service providers as well as clinical trial sites
  • validating computerized systems according to GAMP-5

Explore available eLearning:

 

coming soon

Clinical Excellence Community

Unlock the power of 
spotlighted information delivery:

- Stay ahead with essential Guidelines, expert Tips,      and Practical Solutions

- Enable a smoother Clinical Trial Oversight,                 enhanced Efficiency, and strategic Decision-making

- Get navigated through the evolving landscape of       Good Clinical Practice

Let's support each other!

- Expand your Clinical Operations Network

- Discuss Clinical Trial Challenges

- Share Experiences between Industry Peers

- Discuss Industry Best Practices

- Align on Optimizations and Innovations

- Get an Overview of updated/new Guidelines

Jessica Cordes
Clinical Operations Expert

since 2009 working in Clinical Operations

worked for big pharma and several small-midsized biotechs

since 2013 working for Oncology clinical trials
 (including heamatooncology as well as solid tumors)

since 2018 working for ATMP clinical trials

Jessica Cordes
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