Unlocking Better Outcomes in Bio-IT: 3 Strategies to Drive Value and Mitigate Risk

Like many industries, Biopharma’s success hinges on speed for drug discovery, product development, testing, and bringing innovative solutions to market. Technology sets the pace for these events, which forces organizations to lean heavily on their IT infrastructure. But developing a technological ecosystem that supports deliverables while also managing the unique risks of Biopharma isn’t simple. 

Data security, costs, regulatory compliance, communication, and the ability to handle projects of varying complexities all factor into the risk/deliverable balance. For Biopharma companies to leverage their IT infrastructure to the fullest extent, they must be able to translate these requirements and challenges to their IT partners. 

Here’s how working with Bio-IT specialists can help unlock more value from your IT strategy. 

Understanding the Unique Requirements and Deliverables of Biopharma Organizations

When we talk about requirements and deliverables in the context of Biotech projects, we’re referring to the specifications within the project scope and the tangible devices, drugs, clinical trials, documents, or research that will be produced as a result of the project.

Biotech projects involve a range of sensitive data, including intellectual property, clinical trial data, and patient data. Ensuring the security of this data is critical to protect the company’s reputation and maintain compliance. 

However, this data plays a heavy role in producing the required deliverables — sample specification, number of samples, required analyses, quality control, and risk assessments, for example. Data needs to be readily available and accessible to the right parties. 

When designing an IT infrastructure that supports deliverables and risk management, there need to be clear and measurable requirements to ensure checks and balances. 

Developing Deliverables From the Requirements

Biopharma project requirements involve a number of moving parts, including data access, stakeholders, and alignment in goals. Everyone involved in the project should know what needs to be done, have the tools and resources at their disposal, and how to access, use, manage, and organize those resources. These requirements will define the deliverables, which is why good processes and functionality should be instilled early.

When developing IT to support the movement between requirements and deliverables, IT teams need to understand what those deliverables should look like and how they’re developed from the initial project requirements. 

Biopharma companies must be able to explain requirements and deliverables to IT project managers who may not share the same level of technical knowledge. Likewise, IT must be able to adapt its technology to the Biopharma company’s needs. This is where the value of working with Bio-IT partners and project managers becomes evident. With deeper industry experience, specialists like RCH can provide more insight, ask better questions, and lead to stronger outcomes compared to a generalist consultant.

Managing Multi-Faceted Risks Against Deliverables

Knowing the deliverables and their purposes allows Biopharma companies and Bio-IT consultants to manage risks effectively. For instance, knowing what resources need to be accessed and who is involved in a project allows users to gain role-based access to sensitive data. Project timelines can also contribute to a safer data environment, ensuring that certain data is only accessed for project purposes. Restricting data access can also save on computing requirements, ensuring the right information is quickly accessible.

The way in which data is labeled, organized, and stored within IT systems also contributes to risk management. This reduces the chance of unauthorized access while also ensuring related data is grouped together to provide a complete picture for end users.

These examples are just the tip of the iceberg. The more IT consultants know about the journey from requirements to deliverables and the risks along the way, the better they can develop systems that cater to these objectives.

Best Practices for Managing Risks Against Deliverables in Biopharma IT

Given the unique complexities of managing risks and maximizing value across the deliverables spectrum, Biopharma IT departments can follow these best practices to support critical projects:

• Set realistic timelines and expectations. Not setting milestones for projects could lead to missed steps, rushed processes, and unmet objectives.
• Establish clear communication channels. Keeping all stakeholders on the same page and capturing information in a consistent manner reduces missing details and sloppy work.
• Prioritize risks and develop contingency plans. Establishing checks and balances throughout the project helps compliance officers locate gaps, allowing them to intervene in a timely manner.
• Regularly review and update deliverables and risk management strategies. Continue updating processes, best practices, and pipelines to improve and iterate.

Driving Value and Mitigating Risk in Biopharma IT

The importance of managing risks against deliverables for the success of emerging Biotech and Pharma companies cannot be overstated. Creating an IT ecosystem that caters to your specific needs requires a deep understanding of your day-to-day operations, IT’s impact on your business and customers, and legal challenges and compliance needs. Ideally, this understanding comes from first-hand expertise, given the unique nuances of this field. Working with experienced consultants in Bio-IT gives you access to specialized expertise, meaning a lot of the hard work is already done for you the moment you begin a project. Companies can move forward with confidence knowing their specialized Bio-IT partners and project managers can help them circumvent avoidable mistakes while producing an environment that works the way you do. 

Get in touch with our team for more resources and information about managing risks against deliverables for emerging Biotech and Pharma organizations and how we can put our industry expertise to work for you.

Sources:

https://www.brightwork.com/blog/project-requirements

https://www.drugpatentwatch.com/blog/top-6-issues-facing-biotechnology-industry/