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International Clinical Trials
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For CROs, the outlook for 2015 brings both good and bad news. On the
positive side, according to recent research, one-third of trial sponsors
expect their spending next year to increase by 10%, and most anticipate
spending to be the same or slightly higher (1). Less good is that 43%
of those companies also said they have reduced, or plan to reduce, their
number of outsourced partners (2).
In a climate where sponsors
are looking to streamline their operations and simplify their
outsourcing relationships, what do CROs need to do to become – or remain
– a valued partner, rather than surplus to requirements?
The
answer is that CROs need to critically review their operational
processes. Are they using technology to provide better insight and
improve collaboration with sponsors, partners, regulators and review
boards? Or are they still reliant on outmoded ways of information
sharing that complicate relationships and, critically, increase
time-to-market?
In many cases, it seems to be the latter. A new
survey, the Veeva 2014 Paperless TMF Survey: The State of CRO TMFs,
found that only one-in-five CROs is currently using a purpose-built
electronic trial master file (eTMF) application to manage the mass of
documentation in clinical trials (3). This means that the great majority
of CROs are still using paper-based and simple file-share systems to
manage and assimilate clinical data and documents. These outdated
technologies arguably hinder collaboration, and limit sponsors’
visibility and control over the clinical process.
For those
forward-looking CROs that have already implemented them, cloud-based
eTMF systems deliver significantly improved efficiency, visibility and
compliance, and provide the technology backbone necessary to build
sustainable and truly collaborative relationships with sponsors. The
survey shows that CROs using eTMF solutions have experienced major
benefits, including increased inspection-readiness, higher quality trial
master files (TMFs) and improved collaboration with external partners.
Turn to Technology
Traditional
paper or file-share systems are time-consuming and resource-intensive,
requiring an inordinate amount of manual effort to maintain TMF quality
and completeness. Documents can be stored in both paper and electronic
format (making version control difficult) and are often siloed by
functional area or organisational boundary. This inevitably leads to
process redundancies and duplicate documents, not to mention unnecessary
compliance risk – all of which requires time and effort to reconcile.
improved efficiency, visibility and compliance, and provide the
technology backbone necessary to build sustainable and truly
collaborative relationships with sponsors. The survey shows that CROs
using eTMF solutions have experienced major benefits, including
increased inspection-readiness, higher quality trial master files (TMFs)
and improved collaboration with external partners.
When
a typical Phase 3 study can generate many thousands of documents, this
is no trivial matter. Add to this the increasing complexity of study
protocols, the global nature of clinical development and the growing
number of trial stakeholders (CROs, sites, agencies, committees, etc),
it is no wonder the act of simply compiling multiple trial documents
into a coherent and readily accessible TMF has become a massive
organisational headache for CROs and sponsors alike.
Yet
technology exists that can radically improve this process. For example,
using a shared eTMF system in the cloud can provide a single source of
truth during the entire study. All stakeholders – whether investigators,
monitors and even inspectors – can access the same documents and
associated workfl ows. This helps to increase visibility, compliance and
efficiency, ultimately encouraging a trusted and lasting partnership
between CRO and sponsor.
Going Paperless
Paperless
TMF systems – easily and securely accessible by all – remove barriers
between sponsors and CROs. This fosters trust and creates an environment
conducive to real-time information sharing throughout the entire trial
process. Strategic collaboration also improves dramatically when
technology removes internal and external silos. According to the survey,
CROs using purpose-built eTMF systems report significant improvements
in collaboration with sponsors, while almost half of the organisations
surveyed report easier collaboration with sites (45%) and other CROs
(49%).
In addition, the results demonstrate that many CROs can
gain improvements in real-time tracking and viewing of documents (61%),
as well as increased document quality (43%). Jessica Vicari, Director of
Regulatory Support Services and Document Management at global CRO,
Advanced Clinical, explains: “The survey results are eye-opening, yet
point towards a clear-cut way for all CROs to step up their level of
support to sponsors. We invested in a cloud eTMF 12 months ago and
almost immediately began collaborating more efficiently with sponsors.”
Total Transparency
Using
an eTMF application provides a single point of access for both CROs and
sponsors throughout the clinical trial – from site feasibility to study
start-up and through database lock – so everyone is always working with
the most up-to-date versions of documents. With better visibility,
sponsors have more control over content and grow more secure in the
relationship.
Sponsors can collaborate with CROs in real-time
and still maintain a single source of the truth. “With a cloud-based
eTMF, we can provide sponsors with total transparency of trial data and
enable a richer, more collaborative partnership for improved trial
results, including faster time-to-market,” says Gregg Dearhammer, Chief
Operating Officer at top eight CRO, inVentiv Health Clinical.
PharmaStart,
another global CRO, has been able to provide increased visibility and
control to its clients since implementing a cloud-based eTMF globally
across more than 75 investigator sites. Rebecca Moraris, its Director of
Clinical Operations, comments: “Securely accessible in the cloud and as
easy to use as Amazon, our new eTMF ensures both external and internal
teams can fully leverage the system. Everyone can work in parallel so we
do not wait, for example, while documents are shipped to sites or a wet
signature is captured via courier from locations all around the globe.
It also provides total transparency and a better vantage point for
sponsors, sites and internal groups to identify problems early and fix
them quickly.”
Regulatory Best Practice
Paperless
technology enables inspection-readiness too – a top concern of life
sciences companies. CROs using advanced eTMF applications report
improvements in many inspection areas, including reduction of missing
(76%), misfiled (76%), duplicate (72%), incomplete (65%) and expired
(62%) documents.
Furthermore, a
cloud-based eTMF provides a convenient window for health authorities,
which are increasingly seeking electronic access to the TMF. In April
2014, the UK's Medicines and Healthcare Products Regulatory Agency
(MHRA) updated its definition of a critical Good Clinical Practice
finding to include TMFs that are incomplete and inaccessible – difficult
objectives to meet with a TMF system dependent on paper. The MHRA
tightened its parameters on the TMF after repeated inspection delays. In
2013, 33% of sponsor inspections required extra days due to an
incomplete TMF or lack of accessibility. With other regulatory
authorities likely to follow the precedent set by the MHRA, TMFs
worldwide will come under ever-increasing pressure to address these
issues.
Cloud-based eTMFs can mitigate this challenge and
greatly improve inspection-readiness because they are always available
and accessible. Eldin Rammell, a clinical records management expert and
Managing Director at Rammell Consulting, notes: “In the face of MHRA’s
updated definition for critical findings, it is encouraging that
organisations utilising eTMF applications are experiencing significant
benefits in inspection-readiness and business efficiency gains.”
Breaking the Paper Chain
According
to the survey data, CROs are swamped in paper, using more than their
sponsors across all functional areas. Contracts and clinical operations
teams were the most paper-dependent, with 59% of all contracts (52% for
sponsors) and 47% of all clinical operations documents (41% for
sponsors) still in paper format.
In addition, 80% of CRO survey
respondents reported using email, and 65% still rely on paper-based
methods, to share TMF documentation, whereas the number of sponsors
exchanging TMF documents via email (64%) and paper (52%) was lower.
While email is technically electronic, it offers few advantages over
manual paper exchange methods. It is faster, but still an unstructured
communication that is highly insecure and not integrated with the TMF,
which inevitably creates version control issues.
One explanation
for CROs’ continued reliance on paper is an outdated perception that
institutional review boards and ethics committees require wet ink
signatures on physical documents. However, since all major health
authorities now accept electronic signatures, this is a perception that
quickly needs to change.
Going paperless enables CROs to
eliminate slow, risk-prone manual hand-offs, and create new efficiencies
they can pass on to their cost-conscious sponsors. Any CRO that can
demonstrate improvements here – swapping one type of paper for the kind
that pays for new research – provides a tremendous competitive
advantage. Unsurprisingly, 63% of CROs surveyed said that cost savings
were a top driver of eTMF adoption. Another significant advantage is
that, once defined, they can easily be reused from study to study,
speeding start-up on future trials.
Agents of Change
While
both sponsors and CROs stand to benefit from driving industry-wide
transformation with new eTMF technology, CROs have the greatest
opportunity to positively impact the most number of products in
development. One CRO can be involved with many different studies and
their corresponding sponsors, whereas a sponsor generally affects just
its own products. In an industry where the top eight CROs account for
more than 66% of all clinical trials, their position as agents of change
is a considerable one.
As sponsors increasingly outsource
clinical operations, including TMF management and oversight, it is CROs
that can gain the most from more automated and streamlined clinical
processes. While sponsors benefit from real-time status updates,
improved trial quality and inspection readiness, CROs benefit from a
more efficient, scalable model which enables them to leverage technology
across hundreds of trials and thousands of sites. The survey shows that
CROs report large improvements in standard operating procedure
compliance (41%) and improved document quality, with fewer quality
control findings with their eTMF applications than their sponsors (23%
and 43%, respectively).
IDDI, a biostatistical and eClinical
services provider headquartered in Belgium, has not looked back since it
transitioned to a cloud-based eTMF application. “We were looking to
move from our hybrid system [part paper and part online file-share] to a
single, digital solution for improved quality, efficiency and control,
while allowing our colleagues and clients to easily access data through
the cloud,” explains Chief Operating Officer, Linda Danielson. The
company migrated most of its active studies to a cloud eTMF in 2013
followed by 40 new studies in 2014, and reports improved partnerships.
“Our eTMF enables effective collaboration since sponsors can review,
edit and approve documents in real-time.”
Long-Term Survival
Life
sciences companies are evolving away from what have been largely manual
TMF processes and simple file-shares, towards advanced eTMF
technologies to enable paperless trials. In fact, the number of TMF
owners actively building or evaluating eTMF applications to support more
efficient collaboration throughout clinical trials is up from 17% in
2010 to 34% today, according to a 2014 Drug Information Association TMF
Reference Model survey. In the industry’s big push forward, CROs cannot
afford to lag behind. There is too much to lose and much more to gain by
embracing e-collaboration.
“CROs have a tremendous opportunity
to distinguish themselves from the pack and position their organisations
as long-term partners,” says Ken Getz, Director of Sponsored Research
Programs and Professor at Tufts Center for the Study of Drug
Development. “There is a lot at stake for all parties, so it is vital
that CROs urgently build the modern infrastructure, top talent and
compliant processes that will lead to efficient and safe drug
development.”
Sponsors may be embracing cloud-based
collaboration, but CROs still have a major opportunity to drive wider
industry acceptance and use. Early adopters have already reaped
significant benefits, including streamlined operations, increased
visibility and access, and improved collaboration across the clinical
ecosystem. These forward-looking CROs are well-positioned to survive the
streamlining cull and establish themselves as long-term partners,
critical to the success of sponsors.
The Veeva 2014 Paperless TMF Survey: The State of CRO TMFs examines
the current state of eTMF adoption among sponsors and CROs, as well as
the benefits, drivers and barriers to implementing electronic processes.
It is available at www.veeva.com/cro-report
References
1. Positive outlook for outsourcing, Pharmaceutical Technology,
31 August 2014. Visit: www.pharmtech.com/pharmtech/feature+articles/positive-outlook-for-outsourcing/
articlestandard/article/detail/851267?contextcategoryId=43497
2.
Strategic partnerships yet to fully catch on, Outsourcing-Pharma.com, 29
October 2014. Visit: www.outsourcing-pharma.com/clinical-development/strategic-partnerships-yet-to-fully-catchon-tufts-report-finds/?utm_source=newsletter_daily&utm_
medium=email&utm_campaign=29-Oct-2014&c=Ogz+yKt5Hqacyp6PbXQ+DazKY43eeIzO
3. Veeva 2014 Paperless TMF Survey: The State of CRO TMFs, Veeva, 7 October 2014. Visit: www.veeva.com/cro-report
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Clinical Trials in Emerging Markets: Goldmines or Landmines?
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Over the past decade, biopharmaceutical companies
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