Creating credible science

Key for pharma companies selling drugs, devices or services is that the information about the efficacy and safety is trusted and answers the questions of authorities, prescribers and patients. Therefore the main goal of each pharma company should be to be the most trusted source of qualitative information needed.

The start of the standardisation process

In the nineties, Good Clinical Practice (GCP) was globally accredited to ensure the rights and safety of trial participants and scientific research with credible results.

GCP audits were carried out by the authorities and therefore triggered a full implementation throughout the pharma industry. To ensure that their clinical research met the GCP guidelines, companies defined and implemented GCP Standard Operating Procedures.  

This standardisation resulted in a significant increase in time and cost required for clinical product development. Which in turn triggered a significant number of initiatives to improve efficiency, as well as providing information in a faster and more affordable way towards approval-authorities and prescribers.

The globalisation of clinical development

This striving for efficiency resulted in the globalisation of clinical development in big pharma. Many companies started organising their resources in different formats of matrix structures. Thereby different functions (therapeutic area experts, global trial managers, clinical research associates, statisticians, data managers, legal experts…..) were grouped in global or regional expert teams who delegate resources to clinical trial teams when needed.

Continuous efficiency increase

The performance of these efforts was evaluated through monitoring KPIs; how time and budget milestones were met for each step in the clinical trial process. Based on the outcome, processes were often altered to meet specific goals.

In the same endeavour for efficiency, pharma companies started automation of communication with electronic case reporting (eCRFs) for data gathering, email, portals, electronic training and virtual meetings. Combined with the strive for efficacy, this resulted in decreasing face-to-face communication between the clinical team and investigators. 

Especially in big pharma, the ownership of specific process steps and the associated milestones got assigned to specific functions. In many cases, this led to siloed operations. So over the years, efficacy got better and cost awareness got more prominent in the process. This increase in efficiency did not necessarily result in faster and cheaper research, as demands and complexity increased. Unfortunately, along the way, we did lose our personal relationship with investigators and thorough understanding of patients’ needs.

To conclude

Therefore, an overall evaluation of your company’s strengths, weaknesses and opportunities compared to the competition needs to be part of future projects. Key is not only to compare within your own league, being the best is not necessarily the privilege of the leading companies. On top of that it’s important to listen to all of your different stakeholders, investigators and patients included.

Read our upcoming article: “Evolving towards A customer-focused pharma industry”

We are specialised in organisational transformation in the pharma industry. Do you want to improve your evaluation process in this perspective? Contact us for more information.