Clinical services

1MED provides full CRO services covering each step of a clinical investigation, from First In Human (FIH) to observational registries

1MED is a full service CRO offering solutions in all steps of your clinical trials with the utmost care and consideration for the patient.

Our connections in the industry allow us to find the most suitable fit for your needs and to be flexible with emerging trends in submission procedures. We also offer “clinical trials rescue programs” to help Companies to correct poorly designed clinical trials.

We are not just another CRO, we are your collaborative proactive partner

Our proactive approach has helped us in providing better solutions to our clients. Arising issues are faced and resolved in nearly real-time, whilst never loosing focus on the study’s primary objective. This approach allows to maximize the cost-effective use of Company’s resources in achieving their goals.

We can support you for the following activities:

   Study Planning, preparation and project management:

  • Clinical Development Plan (CDP) preparation from FIH studies to confirmatory
  • Clinical study design (pre-market and post-market)
  • Site selection
  • Study documents preparation
  • Project Management Plan
  • Monitoring Plan

   Study Initiation and Submission:

  • Submission of study dossier for EC and CA

  • Site Initiation Visit (SIV)

  Monitoring activities:

  • On-site & remote monitoring
  • Close Out Visit (COV)
  • SAE Management

  Data management, e-CRF and e-TMF:

  • Data management, e-CRF and e-TMF:
  • Set-up and maintaining of CRF and e-CRF, CRF validation and publication
  • Clinical data management
  • Set-up and maintenance of the e-TMF
  • Data base clouding

    Biostatistics:

  • Sample size
  • Statistical analysis of clinical data
  • Statistical analysis plan
  • Statistical analysis report

   Medical writing:

  • Clinical Investigational Plan (CIP)
  • Investigator’s Brochure (IB)
  • Case Report Forms (CRF/eCRF)
  • Patient Information Sheet & Consent Form
  • Investigator’s Site File (ISF)
  • Trial Master File (TMF)
  • Final Study Report
  • Investigational Medicinal Product Dossier (IMPD)

   Real-World Evidence (RWE) data collection 

Clinical services

1MED provides full CRO services covering each step of a clinical investigation, from First In Human (FIH) to observational registries

1MED is a full service CRO offering solutions in all steps of your clinical trials with the utmost care and consideration for the patient.

Our connections in the industry allow us to find the most suitable fit for your needs and to be flexible with emerging trends in submission procedures. We also offer “clinical trials rescue programs” to help Companies to correct poorly designed clinical trials.

 We are not just another CRO, we are your collaborative proactive partner

Our proactive approach has helped us in providing better solutions to our clients. Arising issues are faced and resolved in nearly real-time, whilst never loosing focus on the study’s primary objective. This approach allows to maximize the cost-effective use of Company’s resources in achieving their goals.

We can support you for the following activities:

   Study Planning, preparation and project management:

  • Clinical Development Plan (CDP) preparation from FIH studies to confirmatory
  • Clinical study design (pre-market and post-market)
  • Site selection
  • Study documents preparation
  • Project Management Plan
  • Monitoring Plan

   Study Initiation and Submission:

  • Submission of study dossier for EC and CA

  • Site Initiation Visit (SIV)

  Monitoring activities:

  • On-site & remote monitoring
  • Close Out Visit (COV)
  • SAE Management

  Data management, e-CRF and e-TMF:

  • Data management, e-CRF and e-TMF:
  • Set-up and maintaining of CRF and e-CRF, CRF validation and publication
  • Clinical data management
  • Set-up and maintenance of the e-TMF
  • Data base clouding

    Biostatistics:

  • Sample size
  • Statistical analysis of clinical data
  • Statistical analysis plan
  • Statistical analysis report

   Medical writing:

  • Clinical Investigational Plan (CIP)
  • Investigator’s Brochure (IB)
  • Case Report Forms (CRF/eCRF)
  • Patient Information Sheet & Consent Form
  • Investigator’s Site File (ISF)
  • Trial Master File (TMF)
  • Final Study Report
  • Investigational Medicinal Product Dossier (IMPD)

   Real-World Evidence (RWE) data collection 

REGULATION (EU) 2017/745

REGULATION (EU) 2017/745