Trials, tests and tribulations
For several years now, the life sciences industry has been moving away from its traditional, vertically integrated business model, often referred to as the fully integrated pharmaceutical company or FIPCO model, and is now in search of more efficient and nimble research and development paradigms. This is in no small part due to the demise of blockbuster drugs and the current and impending patent cliff facing the industry.
As a result of the move away from blockbuster drugs, pharmaceutical companies have been shedding core competencies and embracing a new development model, often called the fully integrated pharmaceutical network (FIPNet). Under this new paradigm, the industry has been engaging in new partnerships and relying more heavily on outsourcing.
As a consequence, one of the most essential aspects of running a clinical trial efficiently has become the necessity to share critical information between all partners and investigator sites in a timely, traceable and confidential way. This ensures that the document trail is fully auditable (and therefore complies with regulation) and also maximises the window in which companies have exclusive rights to sell a drug.
Phase III of a trial is when document sharing becomes most vital and problematic. There can be well over 1,000 participating patients, more than 50 investigator sites, and several research organisations involved in the study – all spread across multiple geographies in order for research to be carried out in a compliant, timely and cost-effective manner. It is crucial, therefore, that global sites are able to collaborate on research quickly and securely, while maintaining control of critical IP.
With this in mind, it is staggering that recent research has found that 43 per cent of investigator sites continue to exclusively use paper files throughout the clinical trial process. There are a number of issues with this; the most significant being that this process is incredibly time-consuming. It is important that pharmaceutical organisations try to reduce time-to-market as much as possible, without compromising the quality of the study.
In addition to this, in order to get a drug approved by the US Food and Drug Administration, European Medicines Agency or the Medicines and Healthcare products Regulations Agency, it is necessary that the document trail can be demonstrated in the final submission of the research, as stipulated in Part 21 of the FDA’s Code of Federal Regulations (CFR). If a patient based at a site in Italy, for example, suffered an adverse reaction to a drug, this needs to be communicated as soon as possible to every investigator site, as well as to regulatory bodies and ethics committees. Trial sponsors must ensure that everyone affected across the world has seen the file, and must also demonstrate the manner in which this communication was carried out to the FDA.
Logically, digitising these documents is the next stage in reducing the time and cost of a trial, while also providing a more distinct document audit. However, the concept of digitising processes in itself is not a solution, especially when it comes to sharing documents and collaborating securely. Email, for example, is not an adequate way to share sensitive documents from a trial, not only because it doesn’t comply with regulation, but also because it has proved to be an ineffective platform in the past.
So, if more is needed beyond paper documents and email, what type of technology should lab managers be using to ensure secure collaboration, automated workflows and compliance?
Firstly, technology should be delivered via the cloud using a software-as-a-service (SaaS) model. This means there is no additional burden on IT departments and the software can be scaled globally. As for the platform itself, this should have a friendly, role-based user interface so that each party involved in the study requires minimal training and each user only receives information that is relevant to them. Personnel should be able to review documents in an effective and traceable manner, annotating and comparing documents side by side.
The software must also enable CFR Part 11 compliance. This means that any documents shared or edited should be fully traceable, while the software itself should capture all metadata at both the document and file level so it is auditable. These platforms help laboratory managers keep personnel up to date on all training and safety protocols, as alerts and notifications confirm that staff have accessed training material. This is essential for a global study with thousands of concerned parties, as it gives each employee access to the correct training material, which can be monitored.
By deploying SaaS solutions such as these, laboratory managers are able to track information, reduce paper usage and allow access to the most current information available. In turn, by automating crucial processes, pharmaceutical companies can ensure higher levels of compliance, while speeding up time to market.
The FIPNet model is proving successful for the life sciences industry and as more organisations become associated with one research project and the number of individuals involved increases, workflow inevitably becomes more complicated. Yet it is possible for organisations to complete these processes at a faster rate, with a more concrete document trail and a more secure system. The technology is out there, and as more pharmaceutical organisations adopt these secure collaboration platforms the industry will enhance compliance while driving down the costs associated with clinical development.