The Evolution of Emerging Biotechnology Companies

Come on - we can all admit it. The world is not flat, despite what some modern-day sports celebrities and conspiracy theorists might suggest. The Earth is not the center of the universe, and as much as I enjoy dancing, my moves alone will not summon a rain shower. We are people of science, individuals who value data. We understand that theories are solidified through continuous questioning, probing, and challenging. And we know from repeated inquiries and diverse evidence from around the globe that human evolution has shaped us into who we are today. 

Just as humans have evolved, so have companies. Changes in headcount, processes, culture, challenges, and solutions are inevitable. Some companies go extinct, while others thrive, grow, and become incredibly successful. In the life sciences sector, where I have spent the last 27 years, this pattern holds true. Some companies have prospered, while others have not. My focus is on the emerging ones, the startups, and how technology has facilitated their evolution. Note that the following references are meant to be taken with a pinch of humor. 

Neanderthals: This term refers to small companies, typically with 1-10 employees. This category often includes startups formed as university spin-offs, funded by personal savings, "friends and family" investments, or a small external investment. Many of these companies may not have physical office space and instead work from shared office spaces or virtually to save funds. They often rely on external consultants with whom they have prior connections, or they may need to find new ones that suit their requirements. Regardless of their location, their primary goal is to develop a product that will ultimately be approved by regulatory authorities, sold to consumers, and used to treat medical conditions worldwide. 

Collaboration is crucial at this stage, especially in a virtual environment where teams work with consultants. Having the right technology to enable collaboration is vital. While it may seem like an unnecessary expense to some executives, this technology will serve as the foundation for the company's future growth. At this stage, teams need collaborative solutions that do not require servers, IT, or network personnel, and that come without prohibitive costs. Here are some key points to consider when evaluating collaborative document systems: 

• Can we easily collaborate on documentation for peer authoring, review, and electronic signing (when necessary), with configurable workflows to suit our company's needs? 
• Is the software offered in a Software as a Service (SaaS) environment, eliminating the need to install software on company servers (which are uncommon at this stage)? 
• Does the provider have experience in life sciences, and was their software developed by teams familiar with the industry? 
• Is the system compliant with 21 CFR Part 11 requirements for regulatory inspection? (This is crucial, as limited solutions offer this.) 
• Can the system easily share documentation and other information with external consultants and team members in real-time, securely, and without performance issues? 
• Does the solution offer a scalable cost model as our company grows, with a lower upfront investment? 
• Is the provider established, and does the software have a successful track record? 

Companies that address these questions and executives who understand the value of investing in collaborative software lay down a foundation that can be leveraged in early-stage development and through to approval. This approach can help them evolve to the next level at a much faster rate than their modern human counterparts. 

Cro-Magnons: This refers to medium-sized companies with 11-100 employees. They may have expanded their laboratory staff for core compound discovery or sourced talent from elsewhere. The company might be licensing products that have passed preclinical stages and are beginning clinical trials. The foundational elements remain the same-a collaborative software system should already be in place, and now the company needs to build on this as part of its evolution. 

For team members to perform their jobs efficiently and keep pace with the demands of a growing company, they need to be clear about their core responsibilities and duties. As the company is larger and likely to have multiple departments or employees in similar roles, providing hands-on training for each person can be time-consuming and potentially inconsistent, which could negatively impact performance and even lead to non-compliance. Documentation of training is required, even in the absence of a dedicated Quality Assurance (QA) individual or department.  

In many companies of this size, the responsibility for documenting training typically falls to one person or the department head. Life sciences companies often rely on "trackers" (such as Excel spreadsheets) or paper systems, which can allow important details to fall through the cracks, often resulting in incomplete records and lacking easy oversight for globally distributed employees. 

To address these issues, companies of this size need to invest in Learning Management System (LMS) software as part of their platform to continue building their foundation. Here are some key points to consider when evaluating LMS options: 

• Is the software offered in a SaaS environment, eliminating the need for in-house software installation (which is very difficult without servers, uncommon at this stage?) 
• Can the software be administered by a single person (as it's likely the company doesn't have a dedicated HR department yet), and/or does the provider offer managed services for administration that the company can internalize as it grows? 
• Can external contractors also utilize the LMS, with training documentation included? 
• What types of training can be provided? Can we start with simple "Read and Understood" acknowledgments for PDFs or other documents, and evolve to true "eLearning" courses as the company grows? 
• If we decide to offer eLearning, does the system support quizzes, auto-grade scoring, training plans, transcripts, and other functionalities? 
• Does the provider have experience in life sciences, and was their software developed by teams that understand the industry? Do they offer hands-on configuration support? 
• Is the system compliant with 21 CFR Part 11 requirements for regulatory inspection? (This is crucial, as limited solutions offer this.) 
• As we continue to grow, we may have non-native English-speaking employees or sites. Does the LMS offer the interface in multiple languages, and can the provider offer translation of eLearning content if/when needed? 
• Does the LMS provide the ability to set up groups and/or departments and provide dashboards to monitor training progress, ensuring compliance by department and individuals? 
• Does the system offer real-time reporting with the ability to generate our own reports? 
• Does the solution offer a scalable cost model as our company grows, with a lower upfront investment? 
• Is the provider established, and does the software have a successful track record? 

Investing in an LMS at this stage will enable the growing company to integrate quality into its operations, which is critical in the event of a regulatory inspection. If the company decides to partner or sell assets, having easily accessible training documentation is necessary. The questions above should help in selecting a reputable software provider, one that can grow alongside the company's evolution. 

Next Stage Evolution: Congratulations! Your company, and the individuals within it, have learned that rocks can be shaped into tools, and that rubbing sticks together can create fire-a useful discovery for many purposes. The company has invested time, energy, and funds to establish the core foundation of collaborative document management and LMS systems upon which future growth can be built. 

At this stage, the company may have grown to 101-500 employees, or it may have chosen to remain smaller and more agile to preserve precious funds. Work may ebb and flow, and the company might choose to rely on external vendors and outsource some services that are not core to its expertise and culture. The company is likely now involved in clinical trials, either in Phase I or beyond, and starting the journey toward regulatory approval for its products. 

Given the company is conducting fewer than five studies at this point, there are two paths it could take to continue evolving. The next necessary foundational element is an Electronic Trial Master File (eTMF) environment. The company may have acquired an asset from a large company or worked with another company that has study data and TMFs in paper format. At a certain point of growth, this information will need to be accessible globally to relevant stakeholders in an electronic format. 

This is the time to invest in the future with a system that can support the company's own studies, whether conducted with different Contract Research Organizations (CROs) for different studies or with a preferred CRO. The product, study, and eTMF are the company's responsibilities; it will be the company, not the CRO, that regulatory authorities inspect for final approval (and if the CRO is inspected and the outcome is not favorable, the product could suffer). Here are some key points to consider when evaluating eTMF providers: 

• Is the eTMF software offered in a SaaS environment, eliminating the need for in-house software installation? If the company is based in the EU, or conducts studies in the EU, is it General Data Protection Regulation (GDPR) compliant? 
• How intuitive is the software? Does it require extensive training? 
• Was it developed by companies and individuals with expertise in the clinical space? 
• Does it comply with 21 CFR Part 11 requirements for regulatory inspection? 
• Does the provider offer Subject Matter Experts (SMEs) who stay up to date on TMF regulations and offer best practices/workshops to assist the company? The company needs an expert. 
• Has the provider ever been through an inspection directly and/or supported a regulatory inspection for a sponsor? 
• Does the system offer quick job aids and short videos to supplement training, or is the company left to navigate a complicated manual and/or pay for additional training? 
• Does the provider offer hands-on configuration support, or does it simply sell the software and leave the company to figure it out on its own? 
• Can the system provide an electronic Investigator Site File (eISF), and if the company conducts global studies, is the system interface available in multiple languages? 
• Does the system offer real-time reporting with the ability to generate custom reports and conduct searches/filters based on the company's specific needs? 
• Does the solution offer a scalable cost model as the company grows, with a lower upfront investment? 
• Is the provider established, and does the software have a successful track record? 
• Does the system leverage machine learning or artificial intelligence to streamline processes? 

THE NEXT STAGE OF EVOLUTION: The company might still operate virtually with few on-site staff members, outsourcing most of its study work. However, by this stage, it has evolved to a point where it desires more oversight and control. This includes control over various CROs and other vendors, as well as control over the studies themselves. The company is now ready to evolve beyond using Excel trackers or storing everything on network drives or in OneNote. Oversight of multiple studies requires something more robust than a multi-sheet Excel spreadsheet; it requires an investment in a Clinical Trial Management System (CTMS) to collect, report, and analyze relevant information at your fingertips. 

Whether you are a Clinical Research Associate (CRA), Lead CRA, Project Manager, or Senior Manager, select data will be important to each role. If the company is evolved enough to use a CTMS, it should be evolved enough to choose a vendor wisely. Here are some key points to consider when evaluating CTMS providers: 

• Is the CTMS software offered in a SaaS environment, eliminating the need for in-house software installation? If the company is based in the EU, or conducts studies in the EU, is it GDPR compliant? 
• How intuitive is the software? If the company is small, are there multiple roles that allow quick access to relevant dashboards and key information for action? 
• Does the system comply with 21 CFR Part 11 requirements? 
• Does the provider offer SME support with clinical experts to assist during the onboarding process? 
• Does the system offer quick job aids and short videos to supplement training, or is the company left to navigate a complicated manual and/or pay for additional training? 
• Does the provider offer hands-on configuration support? 
• Is it relatively easy to migrate data from Excel spreadsheets, legacy systems, and CROs? 
• Does the system offer real-time reporting with the ability to generate custom reports and conduct searches/filters based on the company's specific needs? 
• Does the solution offer a scalable cost model as the company grows, with a lower upfront investment? 
• Does the provider offer multiple modules to accommodate growth as the number of studies increases? 
• Does the system leverage machine learning or artificial intelligence to streamline processes? 

Modern Humans: The company has made the commitment to go all in. Through discussions with other companies, developing business cases, and attending industry talks, it has realized that moving to a comprehensive platform solution will result in significant efficiencies across the conduct of clinical development. This leads to improved productivity, faster global study startup times, reduced cycle times between study activities, and streamlined product approvals. 

The company is aligned internally on technology and strategy, with a clear understanding of how to work with CROs. While having multiple modules might seem overwhelming, they all work seamlessly across the platform and integrate with external technologies to form a complete ecosystem - a fluid environment. The company has evolved to include: 

• A Robust Quality System: Modules for Document Management, LMS for training, and CAPA Management ensure that quality is integrated from the start. This system ensures staff are familiar with SOPs and are trained for their roles. Any deviations from processes are tracked and reported, so inefficiencies can be addressed. 
• Program and Study Management: The company has evolved to streamline studies at the program level. This involves rapid site identification via the Investigator Database 
• streamlined site and facility evaluation via integrated eFeasibility. 
• Collaborative Authoring for developing necessary study documentation virtually across the sponsor, CRO, and consultant team.  
• Integrated Study Start-Up for distributing regulatory packages and contracts/budgets globally to reduce site activation cycle times (including translations.) 
• eTMF for organizing, tracking, retrieving, and reporting on all documentation related to each clinical study 
• CTMS for management oversight of all studies, viewing and assessing site progress towards subject/patient enrollment, IP supply, and protocol conduct through study closeout. Integration with Electronic Data Capture (EDC) provides clear oversight of clinical trial conduct, rounding out a complete global clinical trial platform. 

Companies that evolve to become "Modern Humans" through leveraging eClinical platforms to execute their clinical programs gain the ability to execute global clinical development programs more rapidly than ever before. Modern eClinical systems allow users to access the information they need quickly and work on the go with minimal disruption, incorporating the technology seamlessly into their daily activities with minimal training required. Beyond the users, the implementation of an eClinical platform yields a return on investment in a short period of time. Companies that choose this path excel, while those that implement only a limited number of modules - or worse yet, no modern technology at all - run the risk of becoming extinct, like the Cro-Magnons. Which type of company is yours? 

Contact us to hear how TransPerfect Life Sciences can help you avoid extinction!