Key Attributes to see while you selecting CRO for your Research Trials

1
Challenges in the CRO Industry Selecting a CRO f
or your Research Trials
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
2
Challenges in the CRO Industry Selecting a CRO
for your Research Trials
Clinical Research Organization for Healthcare
provides clinical-study and clinical-trial
support for drugs and medical devices, wherein
many pharmaceuticals, biotechnology, and medical
device industries having operations in the Europe
Union states outsource research services to CRO
to increase efficiency and improve productivity.
Contract Research Organization for Pharmaceutical
Industry offer services such as Project, Data
and Regulatory Management Contracting Medical
Writing and Site and Medical Monitoring, which
offers the comprehensive benefits for
pharmaceutical companies in Europe Union to make
clinical research trials more efficient
and cost-effective in testing economic period.
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
3
Challenges in the CRO Industry Selecting a CRO
for your Research Trials

• CRO industry Challenges
• The CRO faces multifaceted challenges in the form
  of
• Increasingly becoming complex nature of
  regulatory requirements, GxP compliance, and
  quality.
• High levels of risk associated with the CRO
  business model
• Increasing cost of research trials
• Inability of CROs to absorb high levels of risk
• Fragmented nature of business and continuous
  trend towards consolidation
• Variable nature of quality in the business that
  is influenced by many factors
• Requirement of resource-intensive management
• Decreased cost savings and profitability.
• Research personnel changes and losing
  knowledgeable team members during mergers and
  reorganizations
• Global/local Competition in terms of price
  variation
• Key attributes in selecting a CRO for a research
  trial
• Sponsoring Pharmaceutical and Medical device
  companies generally focus on important
  attributes like confidentiality, quality, cGMP
  compliance, timeliness, project cost, the
  reputation of CRO while choosing their
  outsourcing partner for conducting research
  trials.

CRO structure and financial stability Factors
such as company reputation, structure and their
financial condition and their 2 years past
record performance are all good indicators to
look out for in a CRO while outsourcing clinical
trials
Scientific capabilities and Efficiencies Pharmaceu
tical companies can outsource research trials to
CRO after doing a detailed investigation on
their complex skills and specialized competencies
in the particular research trial area that is
not available in-house.
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.
4
Challenges in the CRO Industry Selecting a CRO
for your Research Trials Service
portfolio Medical Devices manufacturers and
Pharmaceutical companies need to choose a
quality-driven global Clinical Research
Organization (CRO) possessing excellent
therapeutic area expertise and experienced
scientific and medical writers capable of
producing high-quality Clinical Research writing
for healthcare. The CRO needs to offer an array
of services such as scientific medical writing,
physician writing, publication support,
biostatistics, and regulatory writing as per the
European Union state requirements. The Medical
device companies need to choose CRO that has good
capability to produce quality-rich Regulatory
writing for class iii Medical Devices essential
for getting Premarket approval (PMA) and has
extensive experience in preparing Clinical
Evaluation Reports (CER), CE-market studies,
post-market studies etc.
Quality Assurance audit/review Quality Assurance
(QA) plays a critical role throughout the sponsor
company- CRO outsourcing partnership, which
helps the healthcare, pharmaceutical and medical
device companies sponsoring the research to
ensure complete compliance with the Europe Union
State-specific applicable GxP requirements.
Thus, the pharmaceutical and medical device
companies need to look out for these critical
elements while selecting a suitable CRO for their
research trials, which can have a significant
impact on the realization of their business goals
and objectives.
About Author, Dr. Nancy, Editor-in-chief, PEPGRA
Healthcare Pvt Ltd.
2017-2018 All Rights Reserved, No part of this
document should be modified/used without prior
consent PEPGRA Healthcare Pvt Ltd INDIA
Nungambakkam, Chennai, 600 034. UK The
Portergate, Ecclesall Road, Sheffield, S11 8NX.
Emailinfo_at_pepgra.com, Webwww.Pepgra.com.