Clinical Studies Romania

Consultancy

With an experience in consultancy up to a profound level, for generating value on a long term, we as CTG, we want to use our experience and know-how along with the abilities and our potential for developing a personalized program tailored to your specific needs in a complex and ever-changing environment.

Our network of specialists with broad experience and expertise is offering:

  • Product Development Consulting Services*: assistance in product development through the required clinical stages;
  • Regulatory Affairs Services: assistance in the strategy development*, submissions to regulatory authorities up to approvals;
  • End-to-end Biostatistics Services*;
  • Study Design Services* including protocol development & case Report Form design;
  • Medical Information & Communication & Scientific Writing Services* including scientific medical, study specific and general public materials and articles, newsletters, medical information’s, reimbursement files, educational programs.

Project Management

Project Management Services related to your clinical study is a critical success factor in planning, organizing and managing all project resources for accomplishing our defined goals, by means of first identifying tasks and how they should be achieved, making up budgets and preparing the milestones for project completion under strict regulatory constraints. Our dedicated study teams (e.g., Clinical Trial Manager, Clinical Research Associates and Clinical Trial Assistant) follow all the steps for defining, evaluating, implementing and provide support for all projects, offering services of:

  • Ongoing Overall Project Management with dedicated person for your own project during all study phases, once the project initially brought to our attention;
  • Feasibility Studies can prevent enrolment challenges to become a major project hurdle. Are being done according to the investigator’s interest in the medical research concept, on the base of the historical background and in concordance with the available patient population. There are a means of discovering and enlarge new partnerships for the successful study conduct;
  • Project Start-Up / Set-up including revisions and customization of study specific documents, translation and back translation of project related documents in local languages, contractual and financial agreements, regulatory and ethics files setup and submissions, EUDRACT management;
  • Meetings coordination (e.g., investigator and monitors meetings, other project specific meetings) including arrangements for meeting location, meeting logistics, travel and accommodations;
  • Vendors Management is our means of communication with our suppliers, customers and vendors and helps maintaining the relationships with all of them and the more time spent on defining the relationship initially, the fewer issues teams will have to handle later;
  • Site Management and Clinical Monitoring including patient enrolment optimization as main communication line between the sponsor, CTG as contract research organization (CRO) and investigative site staff which streamlines the process of initiations of project up to achievement of project goals;
  • Data Management* by offering high-quality standards and cost-effective solutions;
  • Safety* (e.g. Eudravigilance) related services covers all aspects of medical monitoring and safety product support, including compliant and tailored risks strategies with adequate reporting;
  • EU Legal Representation and QP Release* for non-EU clients, compliant with specifics of EU regulators requirements;
  • Quality Control activities to assure quality for our provided services, whose target is to ensure that the products, services, or processes provided meet specific project requirements and are regulatory compliant;
  • Process Optimization is the way we chose to improve performance, by taking care of all our partners’ requirements. We are flexible, but still we are very strict will our operating procedures;
  • Staffing as resourcing solution;
  • Training services* tailored to your needs.

*Services that could be outsourced

Proven record of quality or work, performance, broad experience and expertise with CTG!