Biopharmaceutical research is a tightly regulated environment, and as a result, good practices (GxP) have been established to help ensure consistent quality results.
For employees working in this field, additional training is both part of GxP and a way to increase compliance with GxP. Highly-trained staff members will be able to work with higher efficiency, understand the reasoning behind the regulatory requirements, and be more likely to comply with regulatory requirements.
Finally, position-specific training can improve teamwork and distribute tasks between employees with little room for error.
Employee training in clinical research: why is it important?
For clinical research managers, human capital constitutes one of the greatest strengths. The total sum of practical and theoretical skills, education, and experience the workforce provides is often tough to replicate. Recurrent and opportune employee training, on the other hand, will offer the opportunity to nurture this existing advantage. In turn, this will increase the company’s standard and help shape its culture.
Training sessions can be delivered as one-time sessions or be part of an ongoing cycle that constantly builds on the existing curriculum. It should be designed according to the organisation’s needs, local regulations, and the current Good Practice standards followed by the company.
Common high-impact topics that should be considered as part of the curriculum include:
- Study-specific knowledge about the protocol or clinical practices used
- Product-specific understanding of the investigational plan, the device, or medication being studied
- Therapeutic area proficiency
- Training on digital technologies or in-house software platforms
- An outline of the procedures required by the Sponsor
- Team building and effective communication
When to provide training?
There are two key moments where employee training should be provided.
The first one is when new employees are onboarded or transferred into a new project. This will help ensure that any tasks taken on by the new member will be carried out with slight variation, even if direct supervision is not always available.
At this stage, clinical trial managers should consider combining on-the-job training or shadowing with traditional educational materials. For companies specialising in a particular type of trial or consultancy, it’s best to include some introductory knowledge about the company’s main strength, even if the employee will not deal directly with that. For example, a patient recruitment CRO will need to provide an overview of how they handle this process, even when onboarding a clinical worker.
This initial training is likely to be repeated for new arrivals, and at different times, it should be designed around an established curriculum. This will ensure a consistent experience for the employees.
The second significant opportunity for training occurs whenever the company adopts new standards, begins using a new program, or enlists in a new initiative. This training will likely involve many employees simultaneously. While some of the contents will be position-specific, including all members in the session will help foster team spirit.
Strategies to build an effective training and employee development plan
Employee training programs can be expensive and time-consuming to plan and carry out. The following strategies will help you ensure this investment truly brings out team-wide gains.
Align your objectives with the approach
Curriculum design must go hand in hand with the type of training being provided. This will help employees retain the imparted information better and will help them connect it with their daily tasks.
When providing background information on a product, disease, or subspecialty, the most common pathway is to follow a traditional fact-based curriculum. Such conventional teaching sessions are also helpful during an employee’s initial onboarding.
However, any training initiatives aimed at quality improvement should focus on the specific “risk points” where errors are more likely to occur. This will help keep the curriculum short and easy to learn. This risk-based approach can be adapted for clinical studies at any stage.
Navigating the line between specificity and adaptability is often tricky. Curriculums that are too vague cease to be helpful – and yet, developing new training programs from scratch can delay and increase the cost of the process.
Ideally, a clear framework that encompasses the company’s central policies and philosophy will provide a consistent background for all. This can then be modified as needed to include ad-hoc content.
Select the delivery and assessment formats carefully
Employee training differs from traditional education in that it needs to be immediately actionable. As a result, traditional lectures, seminars, or even video tutorials progressively leave way for more agile delivery methods. These include:
- Inter-team workshops
- Collaborative exercises
- Guided sample projects
- Interactive meetings
Generally, these strategies will focus on performing tasks that resemble those done at work as closely as possible. They also require participants to communicate and apply the new information given. These activities will favour active learning rather than passive listening.
Finally, for training initiatives used for regulatory compliance, it is also essential to include a record of the training session and its results. This implies including a way to assess what the participants learned objectively. At the end of the training, participants should be mentored and allowed to provide feedback about the materials.
For biopharmaceutical companies, training sessions can help them implement new strategies to increase their quality assessments, safety reporting processes, and the team’s ability to work cohesively. Tailoring each programme to the needs of each role will help ensure that all the information given is relevant and exciting – or perhaps most importantly, that it will be applied at the workplace.
Alicia Saville did her degree in psychology at the University of Edinburgh. She is interested in mental health and well-being.