Clinical trials and the Cloud


Document exchange and collaboration has been a laborious process, with couriers physically transporting documents to and from locations. Such an approach has serious security implications and puts confidential data at risk if documents are lost. Even fax and e-mail have shortcomings, which is why Cloud computing, or hosted services delivered over the Internet, looks an attractive alternative

In an industry that relies heavily on secure data sharing and collaboration with external parties, many are still using antiquated methods. Andy Watson, vice president, Life Sciences EMEA, IntraLinks, highlights the advantages that Cloud computing offers

Traditionally, document exchange and collaboration has been a laborious process, with couriers physically transporting documents to and from locations. Such an approach has serious security implications and puts confidential data immediately at risk if documents are lost. This method also creates many opportunities for confusion to arise, as senders and recipients attempt to locate and track relevant documentation during transit or after they have been delivered and filed away.

Even the introduction of electronic methods such as fax, in years gone by, created a massive time deficit and requirements on manual processing. The nightmare of fax paper jams may be a not too distant memory for some.

E-mail may then be seen as a better option, but this too has its shortcomings both in terms of security and logistics.

The security vulnerabilities of e-mail should immediately raise the eyebrows of any life science organisation’s chief information security officer. Data contained in e-mails can be easily intercepted during ‘transit’ and, as e-mails are not typically encrypted, they are extremely vulnerable. Even once e-mails have reached their destination and the data is at ‘rest’, it can be compromised and accessed by unintended recipients. It is not possible to audit data shared with collaborators adequately to know precisely who has ultimately had access to it; this creates hurdles for organisations needing to remain compliant with various regulations.

When a vast quantity of documentation needs to be exchanged, the sheer size of attachments may also become a roadblock, with e-mail inboxes soon becoming full. Organisations may also set size limits on attachment size, which can potentially lead to employees using insecure, consumer-grade collaboration and file exchange tools to circumvent restrictions. This puts data at immediate risk.

Merely organising the documentation in an easily accessible, logical system can be an overwhelming task. The cost, in both monetary expense and time, soon adds up. As an example, large pharmaceutical companies are typically distributing upwards of a million safety packages to investigators participating in clinical trials each year to various sites located across the world, and methods can vary from geography to geography within the organisation, compounding the problems.

Electronic solutions and technological advances have played a role in improving clinical trial operations, yet secure collaboration beyond the corporate firewall has not kept pace.

Security is the most important consideration

A global study was conducted by CenterWatch in May 2012 on methods used for clinical trial document exchange, with respondents consisting predominantly of clinical research co-ordinators, investigators and sub investigators. The survey found that 76% were using insecure, and often manual, methods of document exchange such as e-mail (64%), courier (7%) and fax (5%). Of the respondents, 66% also reported spending at least two hours a week searching for documents, which translates into operational inefficiency and frustration.

To provide an overall snapshot of the inefficiency of such an approach, sites tend to be involved in multiple studies simultaneously, with 43% stating they were participating in between two and five concurrent studies.

From a sponsor perspective, security is the most important consideration, with these methods not meeting the necessary data security requirements when sharing sensitive and confidential data. The logistical issues such as documents not reaching their intended destination or being filed inefficiently, are a further hurdle. Such missteps invariably contribute to clinical trial delays and increased costs.

looking to the Cloud

Increasingly, pharma companies are engaging in co-development relationships as they seek to reduce costs and time expended during the development process. Cloud computing has become an increasingly attractive prospect, with the potential to streamline the clinical development process, reduce information technology expenditure and provide a more efficient platform for handling vast volumes of data and documentation.

Cloud computing refers to hosted services delivered over the Internet which can take various guises, one of which is known as Software as a Service (SaaS). In a SaaS model, rather than having software reside on desktops, software is located on web-based servers with shared virtualised resources. This allows software to be provisioned on demand and scaled to provide a more flexible solution. This can lead to a reduction in cost of deployment and footprint of the internal IT infrastructure.

With applications delivered through a browser, thousands of customers are able to gain access to a multi-tenant architecture. This offers cost-saving benefits to the business as the IT department does not need to invest in servers or software licensing, and is not encumbered by the need for software updates and patching. The SaaS vendor is responsible for its maintenance and provides a fully validated environment, ensuring a secure and efficient service.

SaaS can be delivered on demand, either through subscription or pay-per-use models, and the level of service scaled, based on the individual employee need within an organisation. With the service hosted, managed and maintained by the vendor, all the user needs is a capable device and Internet access.

Use of the Cloud is growing in the life sciences sector, driven largely by r&d activities and clinical trial management. Significantly, the sector has expressed a strong willingness to adopt Cloud-based electronic document exchange systems, recognising the many benefits they bring in streamlining the clinical trial process. Already, 25% of study respondents reported using a web-based document tool as their main way of exchanging clinical trial documents, and this is rising.

Intralinks is an online solution that automates and streamlines the document-centric processes that occur throughout the clinical trial lifecycle. From site recruitment and study start-up to study conduct and close-out, IntraLinks provides the business process automation and collaboration platform to eliminate inefficiency and redundancy, while reducing risk

Intralinks is an online solution that automates and streamlines the document-centric processes that occur throughout the clinical trial lifecycle. From site recruitment and study start-up to study conduct and close-out, IntraLinks provides the business process automation and collaboration platform to eliminate inefficiency and redundancy, while reducing risk

In the CenterWatch study, 71% of respondents cited instant access to information and a reduction in the amount of paper used, due to web-based document exchange tools, as an advantage. Additionally, 60% stated that being able to keep track of information easily was beneficial and 49% stated it reduced time spent searching for information. It is therefore unsurprising the Cloud is piquing interest.

Clinical trial site feasibility is a part of the clinical trial process that requires the exchange of numerous documents with external parties. As an example, when 50 sites are required, a sponsor organisation would potentially poll upwards of 150 sites to gauge their interest, site personnel study experience and training; trial-required facilities and equipment; and any additional sponsor requirements.

With vast quantities of information needing to be exchanged and managed among many parties, this can create confusion when document exchange is conducted inefficiently. Once this process has been narrowed down to feasible sites, contracts and approvals need to be shared, potentially compounding the problem and adding further delays.

The ability to track information easily with an audit trail is also critical

Being able to track information easily with an audit trail is also critical to the industry. During the initial start-up phase of a clinical trial, vast volumes of documents need to be exchanged with investigating teams around the globe, such as protocols, investigator brochures and budget work sheets.

It is not difficult to imagine how this can quickly become an unwieldy process if conducted manually or via paper-based methods. Merely knowing who has been sent which document can be a logistical challenge in itself.

In circumstances where drugs are being licensed to third parties, document and data collaboration can become an issue of intellectual property (IP) protection. In those situations, it is critical that only authorised personnel are able to view documentation. A full audit trail must be provided to track and monitor activity around specific documents and data, including detail on who has viewed, made edits to or shared the document with other personnel.

With a drug taking upwards of 10 years to go from r&d to drug delivery, any streamlining of the process during development can have substantial benefits, including potentially a saving of millions of dollars in investment.

An electronic exchange system allows organisations to send and receive documents securely and efficiently with third party collaborators beyond the firewall, and apply logical processes and workflows. This ensures the right information reaches the right person and that there are no roadblocks throughout the process. The right Cloud-based document exchange tool makes this process far more efficient, transforming an otherwise labour-intensive process into one that is secure and controlled. Parties in a clinical trial are able, in an instant, to see who has received the relevant documentation, right down to who has opened or edited it.

right tool for the job

The right collaboration tool will centralise all the documents and co-ordination across participants related to a process, and provide a standardised framework to organise and identify data in a logical manner. With SaaS applications being used by so many end users, it is critical that the interface is intuitive and easy to use for all employees and relevant parties. This establishes a clear workflow and business process to trigger important activity automatically. All activity is then tracked and recorded, providing real-time status insight for the clinical operations teams.

Data being sent must also be encrypted, providing heightened levels of security. With collaborators in the life sciences sector sharing extremely confidential and sensitive data, they need to be assured that if a communication is intercepted; the data cannot be retrieved without the encryption key.

Transparency is critical when adhering to compliance regulations

Transparency is critical when adhering to compliance regulations within the pharmaceutical industry, such as the Food and Drug Administration’s (FDA) CFR 21 Part 11 guidelines, which define how organisations must work with electronic records. Year on year, litigation and regulation increases, with tighter scrutiny put in place. It is not uncommon for parties involved in clinical trials to need to maintain trading records for upwards of 30 years in case of litigation holds, which require companies to preserve all relevant data in case of investigations.

Organisations need to be prepared to have computer systems and records available for inspection by governing bodies such as the FDA or European Medicines Agency. For example, to ensure compliance around safety document management when inspected, they must prove that the distribution of safety information documents to investigators conforms to the timelines determined by the regulators.

As companies increasingly need to collaborate with external parties, be it partners or regulators, a greater understanding of the Cloud and how it can benefit the clinical development process is needed. Cloud-based solutions have the potential to eliminate many of the inefficiencies in the clinical process, from the clinical trial process right through to manufacturing and marketing. Massive amounts of data and documentation will always be a large component of clinical activities, but the manner in which companies organise, distribute and collaborate can be vastly improved through a SaaS solution.

Not only can the cloud reduce costs associated with traditionally paper-based manual processes, it can also add a layer of security and control that is simply not possible with paper, keeping life science organisations compliant and regulators appeased. The savings in the cost of physically couriering documents is also of tangible and immediate benefit to development budgets. Through Cloud solutions with routine processes built in, organisations are also able to adapt to increasingly aggressive timeline requirements, and stay compliant with ever changing global regulations in a timely manner.

Cloud, too, promises to help rein in infrastructure investment and reduce strain on internal resources, both in terms of monetary expense and employee time. It is little wonder then, that life science organisations are looking up and taking notice.