Obtaining regulatory approvals for clinical trials can be a complicated process, especially for trials involving multiple countries. Different countries have different regulatory requirements and timelines.
Often the clinical trial approval process can take significant time compared to overall length of the trial, however, Central & Eastern Europe has some of the quickest approval times in the world.
During the regulatory approval process we can save approximately 5 months compared to Western Europe.
In different countries the approval process differs considerably and without insider knowledge of the local markets and legislation, this undisputable benefit can turn into a nightmare for foreign sponsors without the help of an experienced CRO like S&P Pharmaterra.
In every Central & Eastern European country we have local specialists who know the regulatory processes better than anyone. They constantly monitor the legislations and update our procedures accordingly when needed.
Since 1994, we have seen many changes in the local regulations concerning clinical trials. We know each countries specific regulations better than any one else because we have been working in each country since the regulations were created.
Our philosophy in regulatory affairs is be proactive. We do not represent a simple document repository where the sponsor sends all the documents and we just forward them to each National regulatory agency. We actively participate in the process to ensure that all the required approvals and licenses are in place at the right time and in the right place.
Our typical suite of regulatory and clinical trial approval services include:

  • IRB/EC documentation preparation on a per country basis
  • Submission of the IRB/EC documents
  • Management of IRB/EC approval
  • Respond to any IRB/EC queries
  • Identification and acquisition of required licenses for sites'' drug supply
  • Identification of required documents for licensing
  • Submission of the documents for licensing
  • Obtaining licenses
  • Preparation of Protocol Amendments for submission
  • Submission of Protocol Amendments to IRB
  • Obtaining approvals for Protocol Amendments from IRBs

This is only a brief overview list. Every study and every protocol presents some specific and unique challenges and thanks to our flexibility we can react and adjust our procedures quickly and efficiently.