Case Studies
manufacturing
process and equipment validation review, approval and implementation
Overview
CIS was recently retained by a mid-sized global pharmaceutical company
to aid their Quality Assurance department with validating and
commissioning a new start-up biologics-based, multi-product,
disposable, perfusion-based manufacturing suite. Click
here
to
read
the
rest
of
the case study.
GCP/GMP Quality
management system (qms) assessment
Overview
CIS was retained in 2010 by the Clinical Compliance Department of a
growing biologics company to conduct an independent assessment of the
existing Quality Management Systems (QMS) structure and process for
development and maintenance of controlled procedural documentation. Click
here
to
read
the
rest
of
the case study.
Off-Label promotion
Overview
CIS was retained by the compliance department of a small specialty
pharmaceutical company to review existing programs in order to assess
current product promotions for use in a manner that is outside of or
otherwise inconsistent with the product labeling. Click
here to read the rest of the case study.
Medical review of
promotional materials
Overview
CIS was retained by a mid-sized global pharmaceutical company to assess
their current process for medical review of promotional materials and
to recommend best practices for efficient, streamlined process
improvement. Click
here to read the rest of the case study.
promotional speaker
program audit
Overview
CIS was retained by a large
global pharmaceutical company to conduct an internal audit of their
Speaker Programs, including audits of the program records and receipts
generated by field-based employees. Click
here
to
read
the
rest
of
the
case
study.
promotional speaker
program implementation
Overview
CIS was retained by a mid-sized
global pharmaceutical company to provide an in-house compliance
resource to assist the client's established Promotional Speaker Program
team. Click
here to read the rest of the case study.
Quality Assurance -
Key Performance indicators (KPIs)
Overview
Compliance Implementation Services (CIS) was retained by a mid-sized
global pharmaceutical company to assess their current quality systems
and develop Key Performance
Indicators (KPIs) to determine the health
of their quality manufacturing systems. A scorecard was developed to
monitor the performance of the quality system in terms of achieving the
set targets. Click
here to read the rest of the case study.
PDMA Vendor audits
Overview
Compliance Implementation Services (CIS) was retained by a private
pharmaceutical company to conduct Audits
of the vendors managing
their
sample
reconciliation
and
sample
distribution.
Click
here
to
read
the
rest
of
the
case
study.
Invoice processing
solutions provide compliance relief
Overview
CIS was retained by a specialty biotechnology company to process their
quarterly Medicaid Drug Rebate Program
invoices from the states. The
company was interested in leveraging CIS' industry experience to
develop appropriate processes and ensure ongoing compliance with State
Medicaid invoice validation and payment requirements and best practices.
Click
here to read the rest of the case study.
"risk-based"
Approach to compliance
Overview
Compliance Implementation Services (CIS) has been retained by numerous
pharmaceutical companies to facilitate the creation, implementation,
and/or maintenance of compliance
programs. CIS works with clients to
establish a meaningful and effective Compliance Program by applying our
“Risk-Based” approach and tailoring this approach to be practical and
operational within each organization. Once the foundation of a
Compliance Program is in place, the objective of our approach is to
proactively identify and mitigate risks through the effective planning
and execution of risk evaluation and mitigation programs.
Click
here to read the rest of the case study.
Pharmacovigilance
system audit provides a roadmap for growth
Overview
Compliance Implementation Services (CIS) was retained in 2009 by a
specialty pharmaceutical company to conduct an audit of its Pharmacovigilance (PV)
Systems to ensure that key PV Systems remain
fully compliant with relevant ICH and U.S. regulatory requirements and
guidance. The Audit was prompted by organizational changes within the
company over the past 18 months, and by the company’s intent to expand
clinical development activities in the near future.
Click
here
to
read
the
rest
of
the
case
study.
Globalization
Requires SOP Harmonization
Overview
Compliance Implementation Services (CIS) was retained in 2006 by a
leading specialty biopharmaceutical company to assess existing Clinical
and Regulatory Standard Operating Procedures (SOPs) and to
design and
implement a path toward harmonizing global SOPs. The company,
originally headquartered in Europe, relocated its headquarters to the
US and needed to standardize its procedures across all regulatory and
clinical departments.
Click here to read the rest of the case study.
Government
Contracting Assessment
Assessment Overview
CIS was retained by a top ten pharmaceutical manufacturer to
proactively assess the compliance and efficiency of its government
contracting group. Because maintaining ongoing compliance with
government contracting regulations is vital, the group undertook
several internal initiatives, including:
- Monitoring the development and maintenance of
Government contracts
- Improving government contracting processes to make
them more efficient
- Updating policies and procedures related to these
processes
Click here to read the rest of the case study.
Medicaid Processing Department
Assessment
Assessment Overview
CIS was retained by a top ten pharmaceutical manufacturer to
proactively assess the compliance and efficiency of its Medicaid
Processing Department. Because maintaining adequate
documentation of
statutory pricing submissions, contracts and quarterly claims
processing is vital to ensuring compliance with statutes, regulations
and guidance; the department undertook several internal initiatives.
Click here to read the rest of the case study.
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