Book a Meeting

Jessica Cordes

Let's drive your Clinical Trials to Success.

You need a Strategic approach to your organizational development

I support You with:

Organizational Development

  • Defining the organizational structure
  • Aligning on required functions and preparing job descriptions
  • Hiring and onboarding GCP-experienced people

    • Clinical Research Transformation with Artificial Intelligence

    AI Strategy & Governance

    • Developing an AI strategy aligned with clinical research objectives
    • Assessing organizational AI maturity and identifying development paths
    • Defining AI governance frameworks, aligning AI use in clinical trials with FDA and EMA expectations, and others (e.g., EU AI Act, GCP, etc)
    • Supporting the establishment of an AI Competence Center

    AI Use Case Identification & Implementation

    • Analyzing clinical research processes for AI automation potential
    • Identifying and prioritizing AI use cases
    • Supporting the selection and implementation of AI tools and models
    • Facilitating pilot projects and proof-of-concept studies

    AI Project & Change Management

    • Planning and managing AI transformation projects in clinical research
    • Leading cross-functional teams through AI adoption and change processes
    • Ensuring stakeholder alignment and communication
    • Monitoring project progress, timelines, and resource allocation
    • AI-enhanced clinical project management
    TÜV Rheinland certificate Manager for applied AI Transformation

    Clinical Research Strategy

    Clinical Operations Interim-Management

    • Supporting and overseeing your clinical operations team
    • Supporting the preparation of your clinical development plan and target product profile
    • Overseeing your clinical research activities (i.e. quality)
    • Planning timelines, resources, and budget
    • Controlling the clinical operations budget
    • Building a sponsor oversight framework
    • GCP-compliant use of digital systems and AI use in clinical trials
    • Providing vendor governance (covering all clinical trials)

    GCP-compliant Procedures

  • Defining GCP processes (SOP framework),
  • also considering the FDA, EMA, as well as cell and gene therapies (CGTs) / advanced medicinal products (ATMPs), long-term follow-up
  • Preparing templates for GCP documentation
  • Learn more about SOPs and Templates available via:
    • Clinical Excellence Training Academy

    Clinical Research Training

  • Providing training (on-site and live online trainings)
  • Providing digital self-learning trainings via:
    • Clinical Excellence Training Academy

    You need somebody Hands-on for your Clinical Project Management

    I support You with:

    Clinical Trial Planning

  • Supporting the development of a briefing book for scientific advice
  • Leading the risk management process for a clinical trial
  • Providing input related to operational feasible into the clinical trial protocol (synopsis) and other clinical trial documents
  • Performing a country feasibility study
  • Performing a site feasibility study
  • Performing a vendor selection (i.e. CROs, Labs, system provider, etc)
  • Supporting a vendor qualification, incl. reviewing SOPs
  • Negotiating vendor budgets and contracts
  • Negotiating site budgets and contracts
  • Preparing functional plans
  • Preparing the investigator’s brochure
  • Supporting the IMPD development
  • Preparing the informed consent form
  • Arranging translations
  • Arranging patient insurance
  • Arranging patient questionnaires
  • Supporting sponsor oversight for computerized system validations
  • Supporting eCRF/IRT development
  • Supporting the development of eCRF completion guideline
  • Arranging WHO DD dictionary and MedRA coding
  • Supporting IMP label development
  • Setting up a central lab
  • Setting up a drug depot and IMP courier
  • Preparing patient emergency cards
  • Supporting the collection of site-specific documents
  • Arranging an investigator meeting
  • Registering the clinical trial at www.clinicaltrials.gov
  • Ensuring appropriate training specifications and conduct

    • Clinical Trial Conduct

  • Managing the clinical trial as clinical project lead
  • Conducting regular clinical trial team meetings
  • Overseeing vendor performance, incl. regular meetings
  • Initiating, and overseeing sites, incl. site meetings as required
  • Overseeing clinical trial performance (i.e. quality, timelines, resources, budget)
  • Overseeing clinical monitoring
  • Ensuring GCP compliance
  • Overseeing training compliance
  • Supporting DMC meetings
  • Managing protocol and GCP deviation
  • Ensuring data governance (data capture and data cleaning)
  • Overseeing drug supply
  • Overseeing sample analyses
  • Overseeing investigator payments
  • Overseeing participant recruitment
  • Ensuring communication between various internal and external stakeholders

    • Clinical Trial Closure

  • Supporting data cleaning
  • Supporting final drug accountability/reconciliation
  • Overseeing site closures
  • Supporting data review meeting
  • Overseeing database lock
  • Performing final financial reconciliation
  • Supporting the preparation of clinical study report
  • Supporting TMF archiving
    • TogetherStronger
    and benefit from my expertise!

    You have generated promising preclinical data.

    Now, you want to investigate your Lead Candidate in the First-In-Human Clinical Trial. 


    Which Goals will you achieve if you recruit your Patients In-Time by using an experienced consultant?


    We will review together Your status quo and identify YOUR demands.

    We will then prepare an Action Plan to achieve YOUR goals within agreed timelines, budget, and quality. 


    You are interested in a structured approach with fact-based decision-making?

    Do you want to get experienced support to generate your required Clinical Trial Data Package In-Time?


    Book an Introductory Meeting now.

     Book a Meeting
    Join our Clinical Excellence Community
    to accelerate Your Clinical Trials

    Don't miss your chance.

    Sign up today for the regular Clinical Operations Spotlight - a bi-weekly Newsletter.

    My Services

    My Services

    My Services