The Overview
Background
Our client, a global biopharmaceutical company, is committed to delivering truly innovative and life-changing drugs for patients. Their mission is to build a major global biopharmaceutical corporation while focusing on the discovery, development and commercialisation of products for the treatment of cancer and other severe, immune, inflammatory conditions. There are over 300 clinical trials at major medical centres using their compounds, with investigational compounds being studied for patients with incurable hematological and solid tumor cancers. One of their guiding principles is a total commitment to patient support. They put patients first with industry-leading programmes that provide information, support and access to their innovative therapies. Capitalised on the NASDAQ at over US$ 50bn, our client generates revenues in excess of US$ 5bn annually, with a 40% EBITDA.
The Brief
What The Client Asked For
With a significant new product to trial and a partnering contract research organisation (CRO) on board, our client’s European clinical operations team faced a daunting task in getting a robust trial up and running across four continents. The challenging timescales and an aggressive budget meant that it was imperative for the joint client-CRO team to start quickly and effectively, with intense corporate focus on the “first patient in” target.
Additionally, our client was keen to break the mold and do something different. Clinical trials have usually been launched along parallel lines, in which the company’s clinical operations team and the CRO have organised and operated inter-dependently, rather than integrally. It was decided that for this trial an integrated approach would be advantageous and would act as a pilot for future clinical trials.
Having previously worked with Primeast on a project dealing with matrix management, the client again turned to us for support. The key elements of the brief were to:
- Bring a new team together, formally, for the first time
- Agree the vision, values and desired outcomes for the study
- Establish how the team can work effectively together, highlighting expectations, roles, responsibilities and accountabilities
- Develop an outline project time and activity plan for the study
- Identify the key challenges facing the team
- Highlight the behaviours needed to give the team the best possible chance of success
- Agree a Team Charter
The Solution
What We Delivered
Primeast designed and facilitated a two-day kick-off event to meet the brief. The design process included conducting interviews with client stakeholders and CRO managers in order to understand what issues needed to be addressed in a successful project kick-off. The event was then planned in exact detail, including selecting a location and agreeing a participant list.
Importantly, the senior key stakeholders from our client and the CRO responsible for the clinical trial’s success took a visible joint leadership role in opening and then participating in the event, with all the key functions being represented throughout. It was an intensive and interactive experience, but one where everyone participated enthusiastically and valuably.
Another key ingredient that drove successful outcomes was placing the spotlight on the purpose of the study – to save lives and improve patient quality of life. Time was therefore spent during the kick-off engaging the study team with the scientists involved in the development of the product.
The Results
What We Achieved
The kick-off event was lively, spirited and productive, the key output from which was an agreed high-level timeline and a detailed inventory of short-term actions. Importantly, a team charter and ‘rules of engagement’ were also agreed amongst participants, which minimised the demarcation lines between our client and the CRO, as well as those between functions and hierarchies. Furthermore, key issues and potential study trial ‘blockers’ were identified and documented.
Measures were chosen to reflect the developing ability of participants to gain enhanced performance from their team members and typically show substantial improvement in departmental profitability and customer satisfaction. From the outset these results have been impressive and consequently in 2019 the programme entered its sixth year.