Collaboration today is distributed across disciplines, org charts, and enterprises in an internet-enabled environment. These partnerships deliver tremendous benefits through innovative idea generation, shared technologies, lower costs, greater speed and agility, and a range of talents and expertise not always practical to maintain within a single organization. The successful creation, capture, and exploitation of resulting products or Intellectual Property (IP) is one marker of collaborative value. But what happens if your team has worked diligently to secure the protection of your Intellectual Property, but one of your partners hasn’t? Sloppy documentation, accidental disclosure, missing records: all of these things can put your entire R&D investment at risk. There are always unknowns, but instituting good data management practices and technologies such as ELNs, LIMS, and DMS helps minimize the cost of these data risks later in the project by finding issues early.
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Decide up front what documentation will be required.
During the research and development phases, documentation of work can be just as important to focus on as the resulting products. Not all outcomes, however, will require the same level of detail, proof, or review of the work along the way. Documentation needs may vary: not all R&D relationships are necessarily destined for the patent office, but intellectual property is still important to protect.
- Legal protection: Establishing and defending legal rights to intellectual property is completely dependent upon documentation. Copyrights, trademarks, patents, trade secrets, and design rights all have specific requirements.
- Confidentiality: Information used, referenced, or produced may be subject to Business Sensitive, Confidential, Classified, or other type of disclosure restrictions. Prevent inappropriate or inadvertent disclosures of information with policies that govern presentation/publishing of data in conferences, papers, grants, meetings, and communications (including email, chat, wikis).
- Regulatory: Your entire R&D investment could be for naught if you don’t meet FDA or other regulating agency strictures that determine if your product can go to market. GLP, cGMP, ISO, HIPAA, NIST: Someone should know what the individual regulations mean, if they are required, and how to get your organization in compliance.
- Concept Generation: A good lab notebook always includes an introduction with background references and information to the experiment, and a concluding discussion that reviews what happened and what some next steps might be. The notebook should also always capture these “next steps,” including brainstorming sessions and proposals. Now that the US legal system is based on First-to-File (rather than First-to-Invent), it is more important than ever that your organization’s ideas aren’t leaked to competitors; having new ideas in a secure system helps prevent that disaster.
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Get everyone on the same system.
Homogeneous documentation styles, witnessing, controlled documents, notifications, data storage and more are the easiest road to IP protection. Research contained within an ELN management system centralizes resources, unifies effort, and speeds communication. More importantly, having a universal system makes sure that while are doing your best to protect IP, your partners are as well.
- Data Availability: Having a “central” location for access no longer means a physical spot. Resources should be accessible to every person involved in the collaboration, rather than only those on site with access to old-fashioned study binders. The CERF Enterprise Edition ELN stores your data in secure servers that can be accessed from anywhere. Data availability puts your information accessible to those who need it so it can be easily accessed for patent defense. It also makes all of the work you’ve done searchable, so that you don’t have to repeat experiments or scramble to find those results for publication.
- Internal notifications and direct messaging keeps staff members from jumping out or the ELN to their (potentially insecure) email clients to discuss or share data. CERF’s direct email system, email-to-CERF, can be used to capture any communications that do occur in email with a simple carbon copy to the dedicated email address. Inadvertent disclosures and concept generation will be archived in the compliant ELN for later proof if the need should arise.
- Training records are an important part of many regulations, and centralizing them within your system can help PI’s feel confident that workers in partnering organizations or who have come onboard after the program kick-off are up to speed on Standard Operating Procedures, technical training, and documentation requirements.
NAABB is a DOE-funded program that uses CERF lab notebook to bring together 200+ organizations to centralize biofuels research and drive new research initiatives. Read more about how having a universal system facilitates research >
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Security, security, security.
This includes disaster recovery, data backup, role-base access controls, audit trails, computer system security, and other measures that will help safeguard your R&D investments. A system that enables fine-grained control over access brings it all together. Paper-based systems are hard to maintain and audit, but a quality ELN meets both needs for documentation and security.
- Authentication validates a person’s identity; authorization determines what resources the person is allowed to see. Authorization also assigns privileges such as the abilities to read, write, or modify.
- Access control should be both discretionary (individual-by-individual) and role-based. For example, a Primary Investigator should be able to add the technicians on one study have access to the study notebooks, while the rest cannot. In addition, the PI can then assign roles to each team member a read, write, edit, or digitally sign resources.
Remember that not every collaboration is scientist-to-scientist. Suppliers, customers, auditors, IT support, and partners, depending on the industry, may require some level of access to your data. Fine-grained control lets you manage that. - Data storage should be secure and long-term. Many patent and compliance regulations require record retention for specific time periods, even after a study is completed.
Our Chief Technology Officer writes frequently about topics of security and access on our blog. See some of the articles available >
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Peer review often.
While not always a high priority for researchers, frequent peer review is proven to help prevent scientific misconduct, catch mistakes, and lower numbers of repeat experiments. Dreaded auditors will also be less likely to find deviations that set back your development schedule. Program managers should ensure that researchers follow established SOPs and compliance regulations for signing and witnessing notebooks.
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Be prepared for change.
Dynamic business environments may cause changes throughout the lifecycle of your collaboration. Key personnel changes and employee turnover, schedule interruptions, technology updates, corporation restructures, supplier changes, can- and likely will- happen. Having a flexible system in place to monitor training, inventory, and progress, will simplify these times of adjustment. With all documentation centralized in the system, new staff can get caught up to speed quickly and be working productively sooner. With fine-grained authorization management, access to resources can be altered even after distribution.
Partnerships are essential for business reasons, but they also create additional IP risks; protecting your lab data and records is critical to securing your IP rights. As you enter into collaborative R&D projects, be sure to assess risks and implement controls and best practices into your partnerships. Be able to trust – and to verify – because your success is at stake. See whether CERF can help you retain control and drive the greatest rewards from your research and development investment.