Lori McKellar

	In clinical trials, the ability to effectively plan, collect and maintain essential clinical trial documentation is challenging. Driven by skyrocketing clinical trial costs, many life sciences companies now rely on clinical research organizations (CROs) for the majority of clinical trials. While outsourcing to CROs can reduce costs, these partnerships increase the complexity of trial document management. The additional coordination required to collect and maintain trial documents can expose both sponsor organizations and the CROs to compliance risk. Therefore, organizations are increasingly tasked with identifying ways to improve the overall efficiency, coordination and control of clinical trial documentation while following Good Clinical Practices (GCP) and ensuring inspection-readiness.

	To achieve these goals, life sciences organizations must become more strategic in how they manage information. While ensuring regulatory compliance always has been and always will be a must, organizations must drive efficiency and productivity across the clinical trials process and beyond.

	The degree of change that organizations can tolerate is often impacted by their cultural tolerance for risk. Many organizations are still using paper-based processes. Some organizations are using technology to automate processes but often the change is incremental because the underlying process was merely “sped up” through the use of technology. Other organizations have made great strides in completely transforming their processes. Regardless where your organization falls on this spectrum, there are three aspects of the clinical trial process that are potentially ripe for improvement.

	Sponsors, CROs, and clinical investigators all need to be able to easily share information throughout the conduct of a clinical trial. Protocols must be distributed, investigator curriculum vitaes (CVs) must be gathered, and other key documents such as case report forms must be exchanged. The dissemination and collection of these documents often happens via email, scanning and faxing and even good old, snail mail. Therefore, it’s not uncommon for doubts to arise about whether the document being used is the most current version. In addition, the time spent sending; receiving, reviewing and uploading information can be cumbersome and time consuming.

	An investigator portal is one vehicle that can significantly streamline the exchange of clinical trial documentation. A portal, when used in combination of an eTMF solution, provides investigators electronic access to key TMF documents, the ability to upload missing and updated documents and participate in workflows including signing documents with Part-11 compliant electronic signatures. A portal benefits all parties involved in the clinical trial:

		By disseminating and viewing key documents through the portal, both sponsors and investigators can ensure that the latest version of study documentation is being utilized.

		Investigators can easily drag and drop documents directly into the Investigator Portal â no need to email, scan, fax or snail mail documents.

		Sponsors are notified when documents come in, and can quickly access and review this documentation in their eTMF system.

Regulatory Submission of Clinical Documents

	Another area that has proven to be time consuming is the preparation of clinical documentation for regulatory submissions. The FDA estimates that it takes a total of 

 just to submit NDAs each year. Serial review workflows where each person edits a document one at a time, authoring and collaborating in separate systems outside an auditable content management system and manually applying changes can be time-consuming, cumbersome and can add compliance risk.

	If this is how your organization is creating, reviewing and approving documentation today, it’s time to re-think that process. There are solutions that support simultaneous workflows to reduce the total time spent by reviewers editing documents. Multiple reviewers can make their edits in parallel and use Microsoft Word’s familiar “track changes” to edit the document. Even better, a consolidated copy of all previous reviewer comments is automatically generated so that each reviewer can see their colleagues’ previous edits and have context before they make their own changes. When it comes time to consolidate these edits, the primary author can accept, reject and review changes in a single document. This eliminates manual updating documents, keeps all authoring and collaboration within the auditable content management system and increases accuracy and efficiency.

	The final aspect that I’d like to touch on is facilitating communication between key organizational stakeholders. Based on the DIA TMF and EDM reference models, at least 20 documents initiated in the clinical domain will need to “cross-over” for reuse and trust in the regulatory domain. What is status quo today among many life sciences firms is exporting documents from one system and then importing them in the another system.

	So what’s wrong with that? A few things from my perspective. First, they are the same document living in two areas of the organization versus having a single source of the (information) truth. It also creates a scenario where workers are unable (or at least it takes a long time) to find the most recent copy of these documents to fully comply with regulations. Finally, it just doesn’t seem to make sense to be exporting and importing the same document. This inefficiency has to chip away at the speed needed to maintain a company’s competitive advantage. Furthermore, while the drug development process is often seen as a linear process, it really isn’t. Throughout the drug lifecycle, changes can be made that sometimes require additional regulatory submissions such as a protocol amendment.

	Today, document management solutions can enable documents to be linked between domains. Cross-over documents can be linked so that information flows seamlessly across different teams. Users can readily access the same document, regardless of their organizational silo. A clinical author, for example, can see the same Clinical Study Report documents as your regulatory publishing lead. No export, import, data merges, etc. And, should a change occur to the document, all associated stakeholders are proactively notified creating better, more automated communications as your information changes during trial conduct.

	Whether your organization is just starting to move away from paper-based processes in support of clinical trials or aims to completely transform how information is managed and flows across your company, there are areas to target for both productivity and efficiency gains. By re-assessing the current business process, outlining more efficient and streamlined processes and using technology to break down artificial information silos, organizations can decrease the burden on both sponsors and sites, reduce the time from trial start up to closure and significantly reduce the cost burden of clinical trials.

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In clinical trials, the ability to effectively plan, collect and maintain essential clinical trial documentation is challenging.

Lori McKellar

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