Information to managers
Encouragement and facilitation from managers are important for staff to contribute to clinical studies. This is reported by the clinicians at the South-Eastern Norway Regional Health Authority.
The line manager also has an important responsibility for contributing to agreed deliveries, and for ensuring that employees meet their obligations and comply with guidelines provided by the employer.
When an agreement is drawn up by Inven2, the line manager can rest assured that the agreement has been prepared on behalf of both the employer and can be signed without further legal assessment. However, it is important that the line manager reviews and approves the use of resources and milestones that the employee commits to.
Delivery is important in clinical studies
Industry-funded clinical studies can provide patients with better treatment options. They are educational and rewarding. Those who take on the responsibility for a trial need the support of their manager and the clinical study nurse, and of the project coordinator, if relevant. Involvement and participation from radiology, laboratories and hospital pharmacies must also be ensured where relevant. A clinical study is a joint delivery.
Inven2 contributes with a budget template and advice in relation to the budget and other aspects of the process described here.
Inven2 has short, internal processing deadlines to contribute to ensuring that the time from the study is submitted to the contract is signed is as short as possible. We endeavour to ensure that the time from the study is notified Inven2 until the signing takes place does not exceed nine weeks. It is therefore important that we start discussing the budget with those responsible for the study as soon as possible. A short agreement period is important in order to be competitive and it creates predictability for the companies that are to conduct their studies in Norway.
An effectively conducted study with a quick start-up and good recruitment of patients provide income to the department and the best possibility of attracting new studies in the future. Delivery in each individual study is therefore very important.
Inven2 negotiates the study budget and other terms and conditions with the industry partner. Inven2 ensures that the industry partner is invoiced based on completed work by the hospital.
The South-Eastern Norway Regional Health Authority’s funding model stipulates that 11.11% shall be added to the study budget for Inven2’s contribution to contract work, negotiations and financial follow-up. This is Inven2’s fee.