Fee-for-Service CRO Documentation Outsourcing Models

Working for and managing contract research organization (CRO) services does not just require successful execution of a clinical trial, preclinical trials, or medical study for the approval of a new drug or medical device. At its core, it requires ensuring that regulations are followed.

As regulations for conducting clinical trials and other CRO-related activities continue to increase in number, managing clinical trials and keeping them on track becomes more complex.

These complex procedures and an increase in research and development (R&D) spending (due to increased R&D costs) help drive pharmaceutical and biotechnology companies to tap into CROs. This drive will likely result in an expected overall industry growth of more than 6 percent by 2022.

However, handling an influx of last-minute changes can be overwhelming if you lack the manpower. If you are not working for a large CRO or certain projects are taking up your team’s time longer than expected, you may not have enough human resources to handle any last-minute changes. Like the ever-evolving FDA regulations or growing trends in the medical device industry for example.

That is why fee-for-service (FFS) CRO outsourcing models from print on-demand companies offer viable solutions for regulation compliance. These companies often help with expediting, assembling, and printing documentation so that your team can reach regulatory compliance deadlines in time. Here’s how:

1. Revision Services

Complying with FDA regulations often calls for last-minute changes to important documentation. Combing through the pages of FDA guides for good clinical practice or GCP guidelines, such as the guide for using electronic informed consent in clinical trials, can be tedious. This is especially so when you’re trying to ensure your team complies with recent changes.

Moreover, a new administration can also mean new regulations. As of 2017, The White House aims to make changes to the process of FDA drug approval. Since these changes have yet to be defined, they can leave uncertainty in the air for CROs in the middle of an approval process or preliminary clinical trial. This may create a pain point in regards to meeting crucial deadlines. After all, the administrative process alone can take 10 months.

If you’ve invested time and money into preparing documentation for approval only to find that a new procedure is in place, you may be left scrambling to revise your documents to avoid delaying trials and the approval process. However, you can save time and focus more on your research than your revisions, when you use the help of online printing services with the knowledge and experience to handle changes such as protocol amendments or serious adverse events (SAEs).

2. Management and Tracking Services

Managing compliance with changes in regulations also calls for tracking those changes. Clinical trials and medical studies can take a very long time to conduct — eight years on average. If a change occurs and you’re not using the right services to track and manage your trial and all of the documentation that goes along with it, you may be setting up your team and your clients for failure.

It’s also vital that your team follows Good Laboratory Practice (GLP) practices to comply with regulations. Choosing the CRO relationship model that gives you the flexibility you need is important. However, you can use an FFS CRO outsourcing model, such as a service that offers a digital content library or document proofing software, to help track your progress in complying with any changing regulations.

Variable data printing is used to customize documents on the fly. For example, release dates. On-demand print models ensure that you pay only for the services you need when you need them. This includes color coding binders for proofing documents at particular phases of the trial in real-time. You can also use on-demand printing to create recruitment materials, such as consent forms, without a long wait time.

3. Collaborative Capabilities

Staying up-to-date with the changes in regulations requires leveraging a service provider. Select a service provider that:

• Has a trusted content distribution network
• Is not only quick but also understands the process
• Communicates well
• Delivers the products and services to your expectations

Whoever you choose must be in tune with your content distribution strategy. Is it imperative to respond to changes without spending too much time away from other important phases of the trial? Online printing services that offer collaborative capabilities prove helpful in meeting compliance deadlines. Especially when services include document proofing software that enables file sharing. Whether you decide on a strategy that involves digital content distribution or one that requires paperwork, your service provider must be current on clinical trial best practices and regulation changes.

Final Thoughts

It doesn’t matter if you’re working in-house as a CRO professional managing clinical trial activities or you rely on the help of contracted services for your pharmaceutical company during the development of a new drug – you can help accelerate the process of approval by paying for the printing services you need.

With services for document revision, management and tracking of paperwork and consent forms, and collaborative document proofing software, FFS CRO outsourcing models help you accomplish timely responses to evolving regulations. Meeting compliance stipulations by using digital printing services can help save you time and money in the long run.

Learn How Leading Pharma & CROs Manage Print Documentation

Organizations are leveraging the cloud to support documentation throughout every trial phase. Learn how Mimeo partners with leading pharmaceuticals, CROs, and medical device manufacturers to print and distribute documentation on-demand globally.