Life sciences companies are caught between greater opportunity and growing pressure placed on over-stretched resources. Globalization, new and emerging markets, and a steady move toward standardization of submission formats open new commercial doors while posing some difficulties.
By Katja Koesterke-Wagner, Global Head, Training and Process Development, European Operations Manager, Life Sciences BPS, CSC
More and more countries are adopting the eCTD submission format; Thailand, for example, began accepting eCTD in 2014 and will make it mandatory to submit in the format by next year. With so much time and money invested in a product, companies strive to get to market as quickly as possible, which often means parallel submissions across multiple regions – for instance a company might well be submitting in the United States, Europe, Australia, Switzerland, Japan and beyond in parallel.
These demands create a dual struggle for many companies:
1) They lack the systems and resources to build those submissions in the eCTD format, especially in light of the trend toward lean staffing.
2) They often don’t have the know-how and the subject matter expertise in-house to address any regulatory challenges that arise.
The logical step for many companies is to seek a business process services (BPS) partner to fill many of the gaps around managing the peaks and troughs of global submissions. That might include having a partner build the submissions in the required format, while the sponsor company works on addressing their systems gap. The question is, does the vendor partner have the bandwidth and global resources to provide that support, particularly given the quick turnaround required? Can the vendor provide the follow-the-sun support needed not only because of time constraints but also because of the global nature of those submissions?
The second aspect to this is subject matter know-how. Returning to the example of the new Thai eCTD, a company may have submitted previously to the country in non-eCTD electronic submission (NeeS) or paper formats, or – quite likely for many – Thailand is an entirely new market for a company. In either situation, the question of expertise needs to be considered. Do you know what to include in the module 1, what pieces of information you will need to include in which sections, and other nuances unique to the Thai Module 1?
Data, Data and More data
Every submission is made up of enormous amounts of data, which continue to grow as a product goes to market – manufacturing data, supply chain, pharmacovigilance, marketing, and beyond. The data and information – including unstructured information – must be managed in various ways, meaning more resources and more subject matter experts are required.
Among the areas that CSC has expertise in, for example, are CDISC and biometrics. While CDISC is specifically a U.S. standard, biometrics apply to all submissions – the gathering of data from clinical and non-clinical studies for summary documents, putting data and statistics into the right tables and formats to run reports and meet submission requirements, particularly those required by the European Medicines Agency. These types of activities require the expertise of statisticians, and for many companies having that expertise in-house is not possible or practical.
Perhaps the clearest example is the looming Identification of Medicinal Products (IDMP). While guidance documents are still a long way off, companies need to begin to collect all the data from their many systems and databases, and depending on how many products a company has on the market, this could be a mammoth task.
Preparation for IDMP is another area where it makes sense to work with a BPS partner who can provide the data management and data entry services as well as the subject matter expertise around the developing standards and guidances. Data will have to be gathered and filtered into preliminary systems and then, as the guidances come out, that data will have to be formatted to the appropriate standard to build those IDMP submissions. Since much of the data is unstructured, it will require going into submission documents, pulling out data, and dealing with documents in a multitude of languages – all of which will be a huge challenge for companies.
Whether it’s about having enough resources to tackle regulatory submission requirements or the specific expertise for complex areas within the process, staffing remains one of the biggest challenges any life sciences company faces. BPS delivers the flexibility required, so long as the resources and expertise meet the individual company’s needs.
Please visit CSC at Booth #P6 at #DIAEuro 2016 to discuss the changing business and regulatory environment and its impact on your resources.