OCT’s representatives shared their experience of project cost planning and some know-hows for successful forecasting and optimization of budget changes.
OCT Financial Adviser Polina Krasnova explained that project costs are often underestimated. She noted that budgets made by OCT consist of more than 400 cost items, which makes budget planning more accurate and efficient.
‘It is obvious that some line items cannot be forecasted as no one can predict their changes before the start of the study. These are the number of protocol amendments, serious adverse events, data queries, etc. To make our work with such items more effective, we allow for some acceptable budget deviations which are controlled and approved by our sponsors, but do not require additional agreements and do not affect project timelines’, comments Polina Krasnova.
The event organizers also discussed different optimization options. For example, project costs for logistics are decreased due to a big team of local clinical research associates and strategic partnership with an extensive network of vendors.
‘Quality is our first and foremost priority. For this reason, we always explain to our clients that there are some budget items you cannot save on. This is especially true for grants. Our team works with dedicated and reliable clinical sites to ensure rapid enrollment rates and required level of quality. We constantly recognize the importance of data monitoring and finding right vendors’, says Clinical Operations Director Irina Petrova.
Today, OCT team has more than 260 trials completed, and more than 120 regulatory approvals obtained. We provide feasibility studies free of charge as part of bid preparation and launch projects in a timely manner. Our quality assurance system has successfully completed 6 audits by pharmaceutical companies with no major findings. All study data collected by OCT are accepted by FDA and EMA.
Looking forward to seeing you on our next meetings!