Clinical Development Support

advanced-technologies

Experienced study physicians and medical scientists can assist your global clinical development teams. Whether you need routine data review for end-of-trial cleaning or safety reviews to support dose escalation decisions or you just need specialist support to meet a critical deadline Pharmora can provide the resources you need at the times you need them.

Pharmora offers end-to-end medical services covering the entire clinical trial process from protocol development, medical monitoring, recruitment trouble-shooting, protocol amendment, ICF and IB updates, DSMB/IDMC through to completed clinical study report writing.

Pharmora also offers separate pharmacovigilance support for clinical trials to ensure the blind is maintained for blinded trials.

Pharmora medics and scientists provide expertise to cover the entire clinical development programme from FTIH to submission and beyond.

The flexible approach offered by Pharmora allows a seamless interface with your organisation to fill any gaps and ensure regulatory compliance with your clinical development requirements.

We offer a wide range of:

  • Pharmacovigilance Expertise including PSUR/PBRER, DSUR and other periodic clinical safety reports
  • Ad hoc or routine signal evaluations
  • Regulatory support:
    • Preparation of submission documentation to support marketing authorisation applications (e.g. MAA in the EU or NDA in the US)
    • Clinical Overviews (Clinical Expert Reports) to support submissions including licence variations
  • Safety and Risk Management Expertise supporting clinical trials and post-marketing
  • Your first or updated Patient Risk Management Plan (including the new EU RMP template) or REMS

In addition to providing a suite of services from our offices, Pharmora can also provide pharmaceutical physicians or pharmacovigilance scientists for in-house projects, arrange consultants for short-term contracts or provide tailored training packages for your staff in house.

For more information please get in touch.