First-in-man studies (FIM) are our primary focus. On yearly basis we conduct a number of SAD and MAD studies sponsored by European and US biotech companies of any size.  We are experienced in leading the way in first human trials. This includes everything from starting the process to reporting the final study results. 

Our group of clinical pharmacology experts have the right experience on designing studies that are crucial for submitting New Drug Applications (NDAs). Our journey starts by getting approval from the European regulatory authorities for each study we contract.

Our purpose-built Phase I-unit facility ensures strict patient oversight, essential for conducting ascending dose studies safely. Based on our internal procedures, we’re able to quickly identified/ screen and randomize clinical study participants for each clinical trials protocol. 

We cover any healthy volunteers’ demographic factors like age, gender, and dietary effects. Convex investigational team are not only quick in the recruitment process but have impressive ability to keep participants involved in short or long studies until their completion.

Here is a list of our clinical research services we provide for First-In-Human (FIH) study: 

  1. Clinical study feasibility process
  2. Project start-up
  3. EU Certification and batch release of sterile and non-sterile investigational products
  4. Import in EU of investigational medicinal product
  5. Secondary packaging of investigational medicinal products
  6. Scientific and regulatory consulting
  7. Study Design and protocol writing
  8. Inform consent form development
  9. Regulatory submission package preparation
  10. Lead RA/Sponsor meeting
  11. Site initiation process 
  12. Clinical operations – SAD & MAD clinical conduct
  13. Subject Identification & Reimbursement
  14. Safety lab assessments
  15. Imaging diagnostics
  16. Clinical trial monitoring
  17. Safety reporting
  18. Vendor management
  19. On-site management
  20. Study/ Vendor contracting and accounting 
  21. General Project management
  22. Quality process – Audits of Investigators/Sites/Vendors
  23. Regulatory Inspection Assistance
  24. Biometrics – Data management
  25. Biostatistics – statistical programming/analysis
  26. Medical writing and reporting
  27. Sample analysis – PK/PD
  28. Clinical study report development 

Convex has years of experience in planning, executing, and documenting First-In-Man (FIM) clinical trials on small or large molecules, in variety of clinical study designs. We have the know-how, the dedicated clinical research unit, and all internal processes / clinical strategy to ensure top-notch results quickly and smoothly.