RocketStart Your Clinical Trials
Clinical trial start-up is most probably the most critical time within a clinical trial: most of the times several months and sometimes even years were spent to come up with a clinical study outline satisfying all stakeholders, clinicians, regulatory specialists, authorities (scientific advice, etc.), program managers, and – last but not least – executive management, and now no further time should be lost whilst starting up a clinical trial. ProjectPharm has developed tools and techniques to overcome the contradicting requirements of delivering a sound project plan, which require a team of experts (regulatory specialists, clinical operations, data managers, statisticians, drug safety specialists, and many more) to cooperate with high focus on the clinical trial, as well as being able to come up with an approved project baseline within a short period of time.
For this purpose we apply a combination of PMBoK and Agile project management techniques to a clinical trial process map, prioritising critical and urgent processes. Coordinated iterations of the planning process ensure that all team members interact whenever necessary, and at the same time keep the focus on the completion of their individual tasks. This ensures that a project-team-wide consensus of the quality requirements will be reached, that the interfaces between the many processes are well-controlled, and that responsibilities of each individual project team member are absolutely clear and unequivocal.
In fact, almost infallibly during clinical trial start-up several pitfalls for the project team are created, be it because the set of plans compiled by the various specialists inconsistently define certain roles and responsibilities, be it because the time pressure leads project team members not to use general templates, but rather adapt the respective (monitoring, drug safety, start-up, or other) plan from another, previously run trial, without noticing that this may not be a perfect fit for the current clinical trial, and – more importantly – that this may lead to significant inconsistencies with other plans, most probably deriving from other projects. This situation infallibly leads to serious quality issues, which in turn will have to be corrected by corrective actions associated with delays and budget overruns, or – worst case –to non-acceptance of the study by the authorities.
Please contact us to know more about rocket-starting your clinical trials, or to discuss a potential project with us.