Introduction
Outsourcing lab IT is more than just a net positive for productivity during drug discovery and development: It is also a path toward a more sustainable future for the pharma industry. Through efficient outsourcing, pharmaceutical companies can potentially raise their stock prices and improve perceptions of how they operate. But first, any consideration of lab IT outsourcing will begin with a tabulation of the expense and complexity of handling everything in-house.
The evolution of lab technology in the pharmaceutical industry has reshaped drug discovery and development. Modern LIMS consolidate multiple functions, including sample tracking from request to registration, workflow management, and data storage, on one platform. Similarly, manufacturing and quality control both benefit from reliable batch traceability in ERP systems.
Advances in data analytics solutions have also made it much more practical for lab teams to scale their work. Instead of needing to run thousands of trial-and-error experiments by hand, automation enables more efficient parallel processing of multiple types of experiments. Plus, detailed reports on such discovery activities are easier than ever to share via ELNs, allowing for an accelerated and more transparent development lifecycle.
At the same time, the ongoing progression of lab IT is only sustained by major investments in equipment, software, and technical expertise. Managing the necessary resources is not only costly but also outside the core competency of pharma firms. Outsourcing these functions is often a practical alternative to developing an internal IT team for handling them, albeit one that should be evaluated in terms of what a particular managed service provider can deliver.
Considerations for outsourcing: Basic rationales and benefits
Any consideration of lab IT outsourcing will begin with a tabulation of the expense and complexity of handling everything in-house. For starters, the costs of outfitting lab personnel with specialized hardware and software are high, typically much more than what an organization can expect to spend on general IT services like giving every employee a workstation.
The instruments alone can cost six figures or more. Furthermore, lab teams need capable computers connected to their instruments, in order to support uploads to informatics pipelines as well as in-depth data analysis. Copious amounts of information are created from preclinical discovery onward, making reliable connections between instruments and IT systems essential.
In the process of ensuring lab teams receive everything they need, there can be some disconnects between corporate IT departments and personnel working with instruments in labs. For example, corporate IT might think it is feasible to shoehorn a business-side solution into a lab environment, when in reality the associated financial (i.e., licensing costs) and operational (malware and technical overhead) risks are considerable. This disconnect between general-purpose and lab-specific IT can jeopardize instrument performance and drain productivity.
Indeed, supplying a lab with the right IT infrastructure requires recognizing the sharp distinctions between what types of applications lab systems will run and those more characteristic of enterprise (non-lab) IT. Going back to the example above, a corporate PC that struggles with standard business software such as office suites or CRMs will not fare well in even more demanding laboratory settings, in which they will have to process data from a high-performance instrument. Tasks that should take only seconds to complete instead finish in minutes.
More broadly, corporate IT could lack the bandwidth to evenly support all teams across the organization. Lab personnel may have to take the initiative in directing IT staff on how to support specific projects, since they have a unique understanding of the instruments and science in play. While this setup can help ensure proper direction in getting the right resources to the right individuals and groups, it detracts from the core purpose of the lab, namely scientific research.
These various financial, procedural, and technical issues can affect pharmaceutical companies of all sizes. That makes outsourcing to a proven managed services provider a viable solution, whether a firm has already experienced such problems firsthand or is looking to avoid them.
At a high level, outsourcing can:
Reduce IT expenditures
By outsourcing, a pharma organization can begin curbing or eliminating multiple significant IT-related expenses. Rather than hiring an entire team of IT experts for a project, it can entrust technical tasks to an experienced external team. Upfront capital expenditures in dedicated infrastructure can also be transformed into more manageable operating expenses in services. Ultimately, more of the company budget can go toward its core mission of discovering and developing new IP and bringing it to market.
Streamline compliance and security
Complying with data integrity requirements from regulatory bodies like the U.S. FDA is a complex and high-stakes undertaking. Almost 60% of all FDA warning letters in fiscal year 2018 cited data integrity violations, which are frequently attributable to in-house teams lacking the training or expertise to know if non-valid activity is taking place.
An outsourcing partner can support remedial tasks like computer system validation, while also assisting with key data security functions, including updating and patching any vulnerable software to lessen the chance of a breach. Performed in-house, these tasks consume time, effort, and money better channeled toward other projects. Plus, applicable service-level agreements may mean that the outsourcing partner has already been sufficiently trained in remediation of data integrity violations.
Enable a more strategic focus
On that note, outsourcing frees lab IT personnel from having to perform tasks that are not central to scientific research and the drug development cycle. Tactical activities such as instrument system break/fix, user administration, and patch upgrades can be exchanged for a closer focus on how the lab might harness the power of new technologies for process innovation. Making IT services more flexible also has the added benefit of easing the transition into a world in which more tasks flow through virtualized and cloud-based platforms, which are more cyber-resilient, more secure, and improve lab-space optimization.
Overall, lab IT outsourcing enables pharmaceutical companies to direct more of their budgets toward IT strategy and science instead of the granular details of IT implementation and management. Not every pharma firm outsources its lab IT functions, however. In some instances, lab IT is the last pillar of their technical infrastructure that is still managed in-house, existing alongside full outsourcing of general IT services. Whether the outsourced route is the correct one will depend heavily upon the particulars of the managed service provider(s) handling the outsourcing, and how the quality of its solution compares to what an organization already has in place.
Securing the right outsourcing service for modern pharma labs
An ideal outsourcing provider should have extensive experience with specialized IT systems, so that they can seamlessly implement and manage all of the specific hardware and software in question. Such an experienced managed service provider can ensure a consistent process and results for each project, leading to better scalability and flexibility as technologies evolve, more streamlined vendor management, more productive relationships between IT and scientists, and ultimately higher profitability.
Let’s look at each of these benefits in more detail.
Scalability and flexibility in the lab
Innovations such as artificial and machine learning are making inroads into pharmaceutical research. For example, in 2018 a researcher at Washington University in St. Louis used AI to uncover the pathways behind the production of hepatotoxic metabolites in the oral antifungal agent terbinafine, which had previously proved elusive. It is more practical to harness the power of these particular technologies and of modern IT infrastructure in general through outsourcing.
That way, pharma organizations can make sure that big projects, such as the installation of a new production system, proceed smoothly without needing to hire numerous new technical personnel who are in a competitive field and can command substantial salaries. Moreover, systems that need to be scaled to new users and/or across time zones can keep up with demand.
Streamlined vendor management
Relying on OEMs to manage the IT end of a lab (e.g., for instruments) is costly. First, there is the hourly price of each service call. Beyond that, labs have to deal with the complexity of managing multiple vendors and differing license and version levels. The latter is a security risk as well, as outdated infrastructure is more vulnerable to cyberattacks and data leakage. The OEM and IT may also disagree about the cause and implications of a particular problem, resulting in unclear ownership.
Outsourcing consolidates all of these issues. The managed service provider takes care of tasks such as software updates, while also implementing systematic processes for inventory tracking and resource management that simplify upgrades to potentially thousands of computers. Labs can become more productive since less time and effort are wasted on navigating technical issues with vendors.
A bridge between IT and science
One of the biggest challenges in lab outsourcing is finding a provider at the intersection of IT expertise and scientific instrument knowledge. A provider simply suggesting a system upgrade to solve an IT problem is very different from that same partner having been through the process many times in a pharma-specific environment. Understanding the overall science and the various lab instruments in play enables them to deliver a better experience that boosts everyone’s productivity.
More specifically, it’s critical the managed service provider can effectively respond to scientists’ needs and concerns. Doing so requires specific expertise. To that end, PerkinElmer has developed its own certification program to help IT experts master everything required for supporting a pharmaceutical lab environment today.
Company profitability and sustainability
By outsourcing, pharma firms can reduce their organizational footprints, save money, and create a more direct path to increased profitability. The costs of bringing even one pharmaceutical to market are high - $2.6 billion, per one estimate - and so being able to trim any costs along the way is desirable. Lab IT is a prime candidate since it presents numerous complications and costs if handled in-house.
Through efficient outsourcing, pharmaceutical companies can potentially raise their stock prices and improve perceptions of how they operate. In this way, outsourcing is more than just a net positive for productivity during drug discovery and development: It is also a path toward a more sustainable future for the pharma industry
Sources:
https://www.pharmaceuticalonline.com/doc/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003
https://www.the-scientist.com/bio-business/artificial-intelligence-shakes-up-drug-discovery-65787
https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html