Developing an investigational drug and attaining regulatory approval is much like the process of building a house.
First, both require coordinating many stakeholders. Building a home requires hiring various tradespeople like carpenters, plumbers, electricians, and more. And you’ll have to oversee and coordinate all their work, which must be done in a certain order. You risk inefficiencies if these functions aren’t carefully managed. What if your painter is ready to go, but the walls haven’t been put up?
Plus, homebuilding has regulatory aspects like making sure that your house is up to building code, you have the right permits with the city, etc. Achieving compliance with all these regulations means extra phone calls, emails, meetings, and potentially more cost. What if you start building, but your permits aren’t in place? The city can shut your construction site down.
What if you’ve never built a house? There are critical building or development tasks you might forget to do, and then you must live in this poorly constructed house.
What if you could hire a single experienced construction firm that could oversee all these activities seamlessly? It’s easy to imagine that your house would be built within your budget, on time, and with peace of mind.
Your drug development program: On solid footing or shifting sands?
Like all the tradespeople needed to build a house, drug development requires expertise that encompasses multiple fields: pre-clinical specialists, clinical pharmacologists, pharmacometricians, medical writers, regulatory strategists, and more. You could hire multiple vendors to do this work. But like with our house example, every vendor added to a study means additional contracts to negotiate, additional groups to manage and coordinate with you and other vendors involved. This complicates managing timing of deliverables between multiple groups to ensure timelines are met. If you don’t have a lot of experience bringing drugs to market, you might miss critical deadlines or end up with a suboptimal regulatory or clinical development strategy. These oversights could jeopardize your drug’s probability of regulatory and commercial success. And that would make you sad.
All the support you need, all under one roof
One solution to the potential fragmentation resulting from managing multiple vendors is to work with a partner that provides multiple specialized services. Certara is unique in that it houses multiple drug development and regulatory science service groups covering clinical pharmacology; regulatory writing; regulatory operations; pharmacometrics; chemistry, manufacturing & controls (CMC); and project management. Each of these groups have experts in their respective fields who have established channels of communication and collaboration with each other. This coordination lessens sponsors’ time spent overseeing multiple vendors. In short, we’re a one-stop shop with the ability to assess any potential gaps in your drug development program, fill these gaps, and project manage the process for you.
If developing a drug is like housebuilding, then our team has a long track record of successfully building houses. In fact, since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA.
What does our end-to-end solution look like?
One example is the synergy gained by coordinating between clinical pharmacology and regulatory writing groups. When designing a clinical development strategy, Certara clinical pharmacologists utilize their experience and expertise to create a blueprint of clinical and virtual studies that ensures that the right data is collected and analyzed to support key decisions.
Our regulatory writers can take this blueprint and incorporate it into a submissions format to highlight key aspects, address all regulatory requirements, and confidently communicate with the regulatory health authorities. Some of the documents that they might develop include:
- Investigator’s brochures
- Clinical study protocols
- Clinical study reports
- eCTD module 2.7.2 (the “clinical pharmacology section”)
This collaboration and coordination reduces the hassle of using multiple vendors for these services.
Ensure that your drug development program has a solid foundation
Finding vendors to support your R&D and regulatory needs is a challenging and integral part of drug development. Engaging a vendor providing integrated regulatory and drug development services can streamline and optimize this process, ultimately saving you time and money and accelerating bringing new medicines to patients.
Contact us today to discuss how we can help support your program!