Case Studies
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featured case study:
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clinical
GCP
standard operating procedures for clinical start up
Overview
Due to the extensive knowledge of its staff, and awareness of related
business practices in a range of clinical R&D organizations,
CIS was retained by an established global specialty pharmaceutical
company to help develop Good Clinical Practice Standard Operating
Procedures for its start-up clinical organization. The company needed
to develop the necessary clinical SOP baseline to document how it would
meet FDA, EU and ICH requirements. 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 indepedent 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.
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.
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manufacturing
SUPPLIER AUDITS ENSURE FULLY COMPLIANT PROGRAM
Overview
Compliance Implementation (CIS) was retained by a Global
Pharmaceutical Company to review its internal and external
audit plan and to audit key external suppliers. Using a riskbased
methodology, CIS evaluated potential patient implications
in addition to collective and compliance risk as it related to
Good Manufacturing Practices (GMP). Once the risks were
identified, they were assessed, analyzed and evaluated. A GAP
analysis was then developed evaluating financial resources,
manpower, timing and the expectable level of organizational
risk acceptable to remediate the deviations that were uncovered
during the inspections. Click
here to read the rest of the case study.
global Quality assurance sop harmonization
Overview
Compliance Implementation Services (CIS) was retained in 2009 by a
mid-sized global pharmaceutical company to assess their Global Quality
Assurance (GQA) prodecural documentation. The purpose of the assessment
was to evaluate all existing GQA standard operating procedures (SOPs)
and associated policies to assist the company in developing a global
strategy... Click
here to read the rest of the case study.
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.
Quality Assurance -
Key Performance indicators (KPI)
Overview
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.
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COMMERCIAL
PATIENT ASSISTANCE PROGRAM / VENDOR ASSESSMENT
Overview
CIS was retained by a top ten pharmaceutical manufacturer to
proactively assess the management of its patient assistance program
(PAP). The manufacturer developed a PAP to provide pharmaceutical
products to patients who are either uninsured or otherwise cannot
afford the prescriptions. The assessment was
based on the manufacturer’s established business rules and key control
documents for the PAP. The objectives of the assessment were to... 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.
state compliance and
reporting
assessment
Overview
State compliance and reporting about interactions with Healthcare
Practitioners (HCPs) is mandatory.
Therefore, it is imperative that pharmaceutical manufacturers ensure
that their state compliance and reporting
program meets the requirements of each state. This case study
highlights the importance of evaluating and improving established
policies, procedures and processes through a state compliance and
reporting assessment. Click
here to read the rest of the case study.
state
reporting and the
lessons learned from preparing state reports
Overview
A pharmaceutical manufacturer retained CIS to assess its state
compliance and reporting processes...while several state reporting
deadlines loomed. Because the company’s compliance department was
limited in resources, meeting the state reporting deadlines became
challenging. Consequently, the company asked CIS to prepare its state
reports and conduct the audits required for state mandated declarations
of compliance. 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.
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.
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government
programs
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.
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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