When your company’s research yields a breakthrough drug or device, it’s easy to get caught up in the excitement. Unfortunately, stress can replace elation all too quickly as the focus shifts from the lab to clinical trials. You need to worry about data quality, patient retention and stringent protocol requirements—and outdated technology and other inefficiencies can throw up further roadblocks.
The road to commercialization is even more complex. You’ve got to ramp up manufacturing to meet commercial requirements, such as serialization, governance over the supply chain and relationships with group purchasing organizations. Multi-country sourcing and distribution demand different skills and tools. At the same time, you must adhere to regulatory requirements.
On top of everything else, you need to beat competitors to market—and that competition is getting more intense. Pharmaceutical companies have seen the typical time a drug stays on the market before a competitor appears dropped from eight years to four, according to research by global consulting firm Bain & Company.
A strong enterprise resource planning (ERP) system is an important investment that can meet all these challenges. With ERP, you can automatically track all aspects of your operations, from R&D through production and distribution, in one platform. Here are nine ways in which the right ERP platform can further your company’s success.
1. Support for Product Commercialization
Many entrepreneurs think of ERP as something only a large biotech firm needs. The right system, however, will support an initiative with a just single product sold in one country and managed by a small staff—and then easily expand to help manage growing supply chains, multi-currency situations and numerous employees spread across different locations.
Going from R&D to commercial production is undoubtedly complex. Automated cloud-based software can manage the many challenges that arise during the entire process.
The biotech industry often deals with matters of life and death. For that reason, manufacturing must uphold precise specifications, and each product coming off the assembly line must be tracked carefully to satisfy safety and regulatory requirements. If a problem arises, you must be able to pinpoint exactly how things went awry and accurately track any product recall.
An ERP solution provides the kind of end-to-end traceability that quickly and appropriately documents processes. Digitization integrates both tracking and compliance into one dashboard.
3. Quality Management
Sourcing raw materials and working with suppliers and distributors requires new processes, personnel and systems. Biotech firms must implement certain quality controls not mandated in other industries to comply with FDA regulations.
The biotech industry must have evidence that it tracks and handles operations according to strict protocols—for example, you don’t want your system to allow ingredients or materials from an unauthorized supplier to slip in by mistake. Some ERP solutions are preconfigured for this kind of validation, making the process faster and less expensive.
4. Security and Data Management
From the start of clinical trials, you need to ensure high levels of security and digital trust when dealing with sensitive patient data, among other information. As you transition to commercialization, your needs get even more complex.
A key benefit of ERP is the ability to retrieve real-time analytics, quality and compliance information from a simple dashboard. The right solution can integrate disparate business processes and systems to give a complete view of your data and operations all in one place.
5. Manufacturing and Fulfillment
As your supply chain grows more complex, you’ll want a system to help integrate all aspects of managing it, such as demand, distribution, production and procurement planning. The right ERP system will provide full visibility into the entire supply chain, helping you standardize operations and drive efficiency as you grow.
6. Inventory Management
Digitization can help automatically identify shortages, changes and other trends that could impact inventory. Real-time oversight allows you to scale up or down as needed.
ERP provides automated supply chain visibility, tracking and transactions. It can be used to map alternative distributors or routes to ensure materials or products are reaching their destination as quickly as possible.
7. Customer Relationship Management
Once you go to market, an ERP platform can automate processes for handling payments, shipping, production orders, stock refills, material orders and other business functions. You can even track sales all the way to your end users.
8. Digital Commerce
Group purchasing organizations (GPOs) are often leveraged to reduce the price of healthcare products. Biotech firms need strong oversight of the components of their GPO contracts, such as rebates and administrative fee tracking, or they risk revenue leakage.
Firms often also need a system that connects with electronic trading exchanges. The right ERP solution will support both electronic data interchange (EDI) and GPO contract management.
9. Recognizing Revenue
Even with adequate funding, most biotech firms still have ongoing concerns about managing costs. ERP solutions simplify oversight by monitoring vendor pricing and the cost of materials in real time, along with other spending variables. The right system can flag cost exceptions and help model alternative sourcing possibilities.
Moreover, robust analytics and reporting capabilities simplify report generation and revenue projections, and an ERP system can help with risk analysis and comparison. Ultimately, ERP offers financial visibility across an organization in one place as it tracks all parts of operations in real time while also modeling future cost and projected-revenue scenarios.
ERP: The Key to Biotech Growth
Making the leap from exploring new product ideas to full-scale manufacturing is both exciting and stressful. A medical breakthrough can change lives, but life-or-death matters come with a non-negotiable need for strong oversight and risk management.
The right ERP solution will serve as the nerve center for your entire operation and provide the transparency required by regulatory authorities. From integrating systems to better managing the supply chain, ERP can simplify the product life cycle process and business operations.
Navigator’s SAP Business ByDesign provides biotech firms cost predictability and scalability from clinical trials through distribution and revenue generation. Learn more about this end-to-end cloud-based platform.