Start-up and Regulatory

We cover all aspects of Start-up and Regulatory operations, including CA and EC submissions, sites and other vendors (labs, depots etc.) contract negotiation, and the corresponding oversight of those activities.

Sponsor’s Legal Representative in the EU

Sponsors which does not have an office or registered address in the EU and wish to perform clinical trials in the EU, must have a legal representative who is established within the European Union.

Site Management Organization – The fastest way to recruit and report

Working with Excellence SMO ensures quality of service and efficiency through experienced and qualified employees who are your main point of contact and single information provider for your project. With its global coverage, Excellence SMO has access to a network of investigators/specialists to manage your multi-centric clinical trials in different therapeutic areas.

S

speedy recruitment

M

minimal cost

O

optimal results

Excellence SMO is a company founded by experienced persons in the Clinical Research industry because the success to your project depends on excellent team support, organizational skills, scientific knowledge, accurate budgeting and communication skills. Currently, the company performs local, regional and international studies in Eastern Europe.
Working with us the benefits are for both doctors/sites and Sponsors.

Our mission is to accelerate start-up phase, to have a successful patient recruitment, and an efficient completion phase. The success of clinical trials is measured in terms of data quality, speed, and cost effectiveness. Our business model ensuring the on-time “delivery” of the contracted number of patients associated with a high retention rate.
Thanks to our global network, Excellence SMO can also propose competitive costs.

Through our contacts and experience, we provide our pharmaceutical sponsors  and contract research organizations with access to the top investigators and a database of over 150,000 patients in Eastern Europe.
3 regional offices across EU as well as presence in other EU countries, we provide access to more than 500 sites and a large network of highly qualified investigators

WHY EXCELLENCE SMO

Due to our model and our coverage we can help Sponsor and Sites to obtain the best results at the end of a clinical trial. We are located in Eastern Europe and this is an advantage.

Some of the advantages of Eastern European coverage are:

  • Population of more than 300 million, 69.4 % of the population is urban (202,505,244 people in 2017), offers a large access to potential patients.
  • Medical centers are usually specialized in multi therapeutic areas and do have access to a very large number of potential patients
  • Healthcare system is well organized and coordinated, best-in-class hospitals as well as outpatient clinics are concentrating most of the clinical trials
  • Combination of both hospitals/outpatient clinics and potential patients provide significant advantages that translated in recruitment rates that are up to 3 times higher than in Western countries
  • Population with large variety of diseases.
  • Rapid access to naive patients.

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