Partnerships + Outsourcing: Strategies for Successful Outcomes
For many companies in the life sciences industry engaging with outsourcing partners is imperative to drive efficiencies in time, money, and personnel, and innovation, say analysts at TechNavio. Optimal use of outsourcing partnerships can help a company lower costs, improve organizational focus, and develop innovative products. Here is a roundup of industry trends, topics, and events relevant to strategies for successful partnerships.
AVOIDING COSTLY CLINICAL DELAYS
As clinical trial costs climb higher and industry pressure towards greater efficiency increase, the need for accurate trial forecasting, budgeting, and vendor selection is vital. Better financial planning, budgeting, and communication can reduce the burden of cost and resource pressures leading to more efficient trials.
Why should the industry take note of this development?
An expansive outsourcing ecosystem enables biotech, medical device, and pharma companies to discover and bring new drugs and devices to market more quickly and efficiently. There are many ways that companies can effectively manage the sponsor-vendor relationship. In this Clinical Leader article, John Carlos Diaz of GeoSera Consulting outlines important guidelines and accountabilities, including understanding the MSA and establishing clear roles and responsibilities.
If this topic resonates with you, you may also be interested in reading this article at Pharmaceutical Online: “7 Speed Bumps to Avoid When Outsourcing Clinical Supply Manufacturing.” You may also be interested in attending Partnerships in Clinical Trials Europe (in Barcelona) or SCOPE 2020 (Orlando, Florida).
TACKLING PHARMACOVIGILANCE ISSUES
According to Sandra Blumenrath of the Drug Information Association, and Catherine Baldridge, of Essential Pharmacovigilance (EPV), pharmaceutical and medical device manufacturers often outsource their pharmacovigilance (PV) activities to vendors and consultants to meet their safety, medical information, and regulatory needs. Inefficiencies in PV activities can slow down product development pre- and post-market, as well as create operational and budgetary strains.
Blumenrath and Baldridge offer a potential solution: “An important step in addressing these inefficiencies is for companies to shift their focus to premarket development and plan for potential signals, audits, and inspections early by involving the PV department at the clinical trial stage. Preparing their PV systems up front will allow companies to collect better and more consistent data prior to market release and be better positioned to enter the market safely while meeting regulatory requirements.”
How can Welocalize Life Sciences help?
Welocalize Life Sciences is able to meet the tight pharmacovigilance reporting turnaround times requested by health authorities to ensure any adverse events/reactions are reported in a timely manner. Welocalize Life Sciences has over two decades of experience translating pharmacovigilance documents, including Serious Adverse Event (SAE), Suspected Unexpected Serious Adverse Reaction (SUSAR), and Periodic Safety Update Report (PSUR).
Medical research organization NAMSA’s “Medical Device Landscape Report” shows that outsourcing spending from sponsors has grown 55% over the last three years, with budgets for outsourcing services expected to increase by 30% within the next few years. Some of the findings show there are increasing prices and profitability pressures that continue to drive decision making in clinical research outsourcing. The report also shows there is a growing cost of clinical trials, which is a contributing factor to sponsors needing to outsource clinical research. Sponsors are also using and relying more on IT solutions like electronic data capture tools and clinical trial management systems. These types of IT solutions are required to conduct effective clinical trials, according to NAMSA.
Why should the industry take note of this study?
According to the study, more regulatory requirements from EU’s Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and International Standards of ISO 10993-1:2018, and ISO 13485:2016 also take away resources from companies looking to participate in clinical trials. Thus, changes in regulatory requirements will impact many different functions in the drug and device production process.
If your organization is interested in partnering with a language services company that has ISO-certified processes and efficient communication practices, contact Welocalize Life Sciences.