Cardinal Health
Specialty Solutions
A strategic partnership
leads to successful outcomes
Regulatory Sciences
How Cardinal Health Regulatory Sciences
built a powerful partnership with a leading
biopharmaceutical company
Situation
A large biopharmaceutical company had several biological products in
development, but did not have sufficient medical writing staff to prepare all the
regulatory documents that were required for various regulatory submissions.
Rather than delaying development of these products while new writers were
hired and trained, the company chose to partner with the medical writers of
Cardinal Health Regulatory Sciences. The initial engagement was for the
preparation of a complex two-part oncology clinical study report based on
numerous source documents that required review and summarization within a
tight time frame.
Cardinal Health Regulatory Sciences
cardinalhealth.com/regulatorysciences
Challenges
The company’s internal writing
resources lacked the additional
bandwidth needed to work on this
project, so they needed writers who
were able to contribute from day one
without a high level of supervision.
This ruled out general contract
medical writers who would need
to be provided with infrastructure
and oversight.
The company also desired medical
writers with a high level of scientific
expertise who understood their
role in the writing and approval
processes. The company needed a
partner it could trust to ensure
the integrity of the data and one
who had the internal quality controls
to deliver quality clinical documents
on schedule.
These needs mandated that the
biopharmaceutical company work
with a full-service regulatory group.
The company needed a team of
medical writers with the experience
to prepare the regulatory documents,
the resources to ensure completion
of the documents according to the
company’s timelines, and the quality
control procedures to ensure the
accuracy of the final documents.
Solution
The company identified Cardinal Health Regulatory Sciences as a strategic
solution. Cardinal Health Regulatory Sciences provides clinical and scientific
guidance for biopharmaceutical companies of all sizes and has a large,
experienced group of dedicated medical writers and regulatory publishers
with deep technical expertise. The Cardinal Health Regulatory Sciences
medical writers have an average of more than fifteen years of experience in
pharmaceutical development and can function as an extension of a client’s
in-house team. These writers are prepared to lead large, multifaceted
projects or provide single-project support. Additionally, with internal
supervision and quality controls, they can manage a medical writing project
or contribute effectively to a joint writing team.
To begin, the Cardinal Health Regulatory Sciences team evaluated the possible
project needs to fully understand the resources required and any additional
requests that might arise. Through their extensive writing experience and
diverse backgrounds working with a number of pharmaceutical companies,
the team was quickly able to evaluate the scope of the project. The Cardinal
Health Regulatory Sciences writing team understood the clinical data, was
familiar with the varying types of source documents, and was experienced
with the company’s document management system.
Cardinal Health Regulatory Sciences
cardinalhealth.com/regulatorysciences
The Regulatory Sciences
experts successfully:
• Developed project timelines
Actions
The medical writers from Cardinal Health Regulatory
Sciences immersed themselves in the client company,
working in its systems and with its associates. The
Cardinal Health Regulatory Sciences team provided the
lead medical writer for the pilot clinical study report and
that writer developed the project timelines and managed
a joint team of writers. The lead writer also managed the
team’s interactions with the company, providing input to
and obtaining input from the multiple departments
responsible for providing scientific data or review of the
report content.
• Managed a joint writing team
• Managed stakeholder input
• Tailored the writing process to
the client’s process
• Guided the report’s content
and completion
Before the project started, the Cardinal Health Regulatory
Sciences writers trained with a member of the client’s
team on its internal systems and standard operating
procedures. This training also prepared the Cardinal
Health Regulatory Sciences writing team to serve as
future trainers for new medical writers
as the project expanded, removing this
burden from the in-house team.
The training also helped Cardinal
Health Regulatory Sciences tailor its
standard writing process to be in line
with the client’s specific process and
templates. Additionally, as the project
expanded, the team was able to
increase efficiency by providing
guidance on development and
implementation of processes and
templates.
Through their knowledge
and understanding of clinical
development, the team provided
guidance on the content of the
report, ensured appropriate analysis
and discussion of the results, and
provided a timely and accurate deliverable.
Cardinal Health Regulatory Sciences
cardinalhealth.com/regulatorysciences
Results
The success of the pilot project exceeded the client’s
expectations for quality and efficiency. The client felt that
having the Cardinal Health Regulatory Sciences team
involved at the start of the project helped produce
higher quality regulatory documents in a shorter
timeframe. The client also appreciated the reduction in
burden on in-house staff as a result of the streamlined
process for training new medical writers.
Based on the success of the initial engagement, the
client has continued to expand its outsourcing with
Cardinal Health Regulatory Sciences. The small group of
medical writers on the first project has grown to
encompass a team of eight medical writers dedicated to
this client. Cardinal Health Regulatory Sciences has
partnered with this client on projects as varied as clinical
and nonclinical writing; chemistry, manufacturing, and
controls consulting; quality assurance reviews; and
publishing activities. Cardinal Health Regulatory
Sciences’ involvement with this client has expanded into
working relationships with other departments and
divisions within the biopharmaceutical company.
The company realized the value added by Cardinal
Health Regulatory Sciences’ scientific and drug
development expertise and assigned the medical
writing staff the high-value, top-priority projects
required for key regulatory submissions. The
company truly views Cardinal Health Regulatory
Sciences as a trusted development partner and an
extension of its staff.
2
writers began
this project
8
writers now work
with this client
Accurate. Accelerated. Approved.
Learn more about Cardinal Health
Regulatory Sciences at:
cardinalhealth.com/regulatorysciences
cardinalhealth.com/regulatorysciences
Cardinal Health Regulatory Sciences
Commerce Plaza II, Suite 300
7400 W. 110th Street
Overland Park, KS 66210
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