Lab diary entry no.3: Four points to consider when forming an outsourcing partnership
In the most recent entry, R&D software provider IDBS highlights four points to look out for when forming an outsourcing partnership.
Outsourcing to contract research/development and manufacturing organisations (CxOs) is a trend that has increased dramatically year-on-year in the pharmaceutical industry. There are many reasons why outsourcing continues to be so popular, despite some concerns within the industry.
Time and cost savings, along with access to specialist equipment and subject matter experts, are prime examples of key benefits, and Deloitte’s 2016 Global Outsourcing Survey revealed how 78% of respondents feel positively about their outsourcing relationships. However, to ensure scientifically robust business-to-business collaboration, organisations need to be able to rely on a R&D informatics technology partner who is able to manage both the dynamic scientific and business critical data flow efficiently, securely and to regulatory standards.
There are four simple things to remember when looking for the right outsourcing technology partner:
1. Security
Establishing a secure network when working with CxOs is essential, especially when sharing sensitive intellectual property (IP). Before starting any CxO collaboration process, sponsoring organisations should review their own data management systems and processes to ensure they are capable of sharing data outside the firewall. If they don’t allow for external sharing, organisations need to vet and assess the informatics solutions available.
There are several Software-as-a-Service (SaaS) solutions that enable secure data sharing outside the firewall, and operating in the cloud allows for fast onboarding of those all-important outsourcing partners. Ensuring all data and IP is safe from intentional or unintentional tampering will allow organisations to focus on selecting the best CxO for the job, without worrying about data flow and data security.
2. Systems integration and platform models
CxOs tasks are assigned and this creates a steady stream of work, which is at the core of outsourcing, but eventually, all the data must be integrated into corporate systems to support downstream analysis, workflows and regulatory submissions.
Many organisations encounter difficulties integrating processes and data generated by their CxOs back into their own systems. This can lead to sponsoring organizations feeling pigeon-holed into selecting CxOs based on their overall IT compatibly, rather than expertise and business drivers. This does not have to be the case — and SaaS platforms can be used to bridge IT systems in a cost-effective manner.
Subscription pricing models also mean you only pay for what you use meaning better ROI. A further benefit is that bridging the informatics landscapes of the sponsor and CxO can also automate and streamline the integration processes of incoming data, shaving valuable time off the drug discovery and development process.
3. Compliance
One of the benefits of outsourcing is having a global market of CxOs to choose from, although operating on a global scale raises regulation and compliance concerns. How can a sponsor organisation in the UK ensure a CxO in China is complying with EMEA regulations?
Advanced SaaS R&D informatics platform solutions allow sponsor organisations to define and embed business and master data management rules into their collaboration systems, ensuring the CxOs comply.
To avoid any compliance misconduct, sponsor organisations should identify what specific rules their CxO partner must comply with before collaboration begins. Communicating this through a scientifically robust informatics data management platform boosts the confidence in the data produced by CxOs.
4. Industry expertise and reliability
Selecting the best CxO for a project requires visibility of a CxO’s accomplishments, credentials and expertise, and sponsoring organisations should thoroughly investigate potential CxOs before outsourcing any work. Similarly, sponsoring organisations need to select a technology partner that can support the complex, scientifically demanding, compliant workflows that are integral for drug R&D.
Organisations that are collaborating should be working as one entity, where work is easily assigned and tracked. Data should be shared and traceable, auditability and compliance should be enforced across teams as required, and all people working on a given project should be visible and accountable.
All this needs to occur while also supporting the overall scientific workflows and reporting requirements through the diverse cross-domain boundaries of chemistry, biology, formulations and analytical sciences. Essentially, it should not matter if a company is outsourcing or not — the work process, data process and informatics systems should not be the barrier — they should be the enabler.