10 most reliable cro’s to watch in 2021

Clinical Research Excellence Built on the Foundations of Quality
,
,We are very
transparent in our
work and prefer a
model in which our
client knows
everything about
the project.
September
Issue: 10
2021
MOST
Reliable CROs
to Watch in
2021
The Right Insight
The Importance of CRO
in the Biotechnology
Industry
#FutureTech
Tracing the Evolu on of
Medical Technology

ealth will remain a major concern until there is
Hlife on earth, and healthcare providers will be on
their toes to deliver optimal results. In addition,
with drastic changes in lifestyles, environmental conditions,
and increasing population, there is a rise in the number of
rare diseases and diverse disease conditions. All these call
for clinical trials and drug development.
Pharmaceutical companies are always on their toes given
the mammoth task of researching and developing drugs.
Here is where Contract Research Organizations (CROs)
come into the picture bringing significant results to pharma
and biotech companies by acting as a catalyst for drug
development.
The CRO industry is snowballing, particularly with the
recent global health concerns. The COVID-19 pandemic
has only accelerated the need and growth of CROs, which
mandated research and clinical trials. The CROs conduct
research and clinical trials for pharmaceutical companies.
They deliver results efficiently. In addition, an increase in
rare diseases and pandemics gave rise to the demand for
research and drug development and consequently to CROs.
Pharmaceutical companies are ready to spend for R&D and
are outsourcing the job to CROs.
Recent studies reveal that the market value of global CROs
is expected to exceed $51billion by 2024.
The CROs are responsible for data research, project
management, tests and trials, and drug development. They
also provide support to medical device industries through
their research.
Graduating from clinical trials and lab services to data
analytics, drug development, and enhancement, CROs have
come a long way. The penetration of technology has eased
their work and has provided accuracy in their results. They
use the latest technologies like AI, big data, cloud-based
trial tracking, and others to improve their research and
analysis.
The CRO market is becoming highly competitive. Many
large CROs opt for acquisitions and mergers. On the other
hand, Smaller CROs are becoming popular due to their
personalized approach and cost-effectiveness. The market
belongs to those who can swim with the tide and yet stand
apart.
Choosing a CRO is vital for the success of clinical trials.
However, it is difficult to find reliable CROs since
pharmaceuticals seek partners who deliver comprehensive
data and reliable outcomes.
We featured a few trustworthy CROs making a difference in
the health space in our latest edition of Insights Care - 10
Most Reliable CROs to Watch in 2021.
Read their journey that we penned down for you and learn
about the developments in the health sphere.
Have a great read!
Sumita Sarkar
Rewriting
Healthcare Solutions

Transforming the CRO
Services with Diligence
1MED
Enabling Pro cient
Clinical Trials
for Healthcare Service
Providers
BIORASI
An Inventive Approach of
Designing and
Performing Clinical Trials
PIVOTAL
Regulating Essential
Clinical Trials and
Observational Studies
SOFPROMED
24
28
36
16
Articles
THE RIGHT INSIGHT
The Importance of CRO
in the Biotechnology Industry
#FUTURETECH
Tracing the Evolution of
Medical Technology
20 32

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Cover Story
Clinical Research Excellence Built on the
Foundations of Quality
08

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Business Development Manager
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September, 2021
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Description
Featuring
1Med
1med.ch
Enrico Perfler
CEO
1Med is an international company of skilled professionals
from the medical device and pharmaceutical industry, from
clinical research and the regulatory field.
A10 Clinical Solutions
a10clinical.com
Favor Winner
CEO and President
A10 Clinical Solutions is a clinical research and clinical care
company that works with pharmaceutical companies.
Biorasi
biorasi.com
Chris O’Brien
CEO
Clinical Trial Service
clinicaltrialservice.com
Mirjam Bruggink
Founder and
Managing Director
Clinical Trial Service B.V. contributes to the optimization
process of qualitatively high and reliable clinical research by
transferring knowledge and experience obtained by setting
up, monitoring and managing clinical research on medicinal
products, medical devices and food supplements.
Link Medical Research
linkmedical.eu
Ola Gudmundsen
CEO
LINK Medical is a full-service Nordic CRO providing product
development services for the pharmaceutical and medical device
industries across Northern Europe.
Dr. Ibrahim Farr
Chairman and CEO
Pivotal is a Contract Research Organization that weaves
together the scientific insight, the technology and the
resources to help customers address both current and future
needs.
Pivotal
pivotalcr.com
Patricio Ledesma
General Manager
Sofpromed is a full service contract research organization (CRO)
specialized in the management of phase I-IV clinical trials in
oncology as well as in cardiovascular, metabolic, central nervous
system, dermatological, infectious, and respiratory diseases.
Syneos Health
syneoshealth.com
Alistair Macdonald
CEO
Vizera
vizera.eu
Mojca Fir
Director
Vizera is an European clinical research organization (CRO)
based in Slovenia (EU) that specialises in clinical trials for
medical devices and nutraceuticals.
Biorasi is a global, award-winning and full-service contract
research organization (CRO) that delivers the speed and
agility that today’s small and midsized pharmaceutical and
device companies desperately need.
Syneos Health® (Nasdaq:SYNH) is the only
biopharmaceutical solutions organization purpose-built to
accelerate customer success.
Clinmark
clinmark.eu
Marek Wasiluk
CEO
Clinmark is a leading Polish Contract Research and
Consulting Organization on the Polish market and CEE.
Sofpromed
sofpromed.com
Company Name

Clinical Research Excellence Built on the Foundations of Quality
,
,Clinmark is a boutique CRO, providing
complete solutions for clinical
development programs, from the
scientiﬁc concept, design, execution till
marketing authorisation.
,,

For pharmaceutical companies to thrive in a
competitive marketplace, it is crucial to have a
strong understanding of the customers’ demands.
Recently, there has been an increased emphasis on Contract
Research Organizations (CRO) as they are seen as vital
partners in achieving significant results for pharma
companies.
The CRO industry is growing at a rapid pace with the
recent rise of global health concerns such as the ongoing
COVID-19, Ebola, Zika, and other diseases. CROs are at
the forefront of drug and medical device development. They
provide a cost-effective way for pharmaceutical companies
to outsource research and clinical trials, while also
mitigating risks by selecting from a variety of CRO options.
As the global healthcare market continues to grow, the
industry is seeing an increasing number of CROs offering
innovative services and solutions that are driving new
treatments forward in the field. One prominent name among
such organizations is Clinmark.
In the following interview, Marek Wasiluk, the CEO of
Clinmark shares valuable insights into the company’s
operations and offerings, the challenges it encountered
during the COVID-19 pandemic, his vision for scaling the
company in the years to come, and much more.
Following are the highlights of the interview:
Please brief our audience about Clinmark, its mission,
and the key aspects of its stronghold within the contract
research niche.
th
This year Clinmark is celebrating its 20 anniversary of
establishment. Over this time, we went on a very exciting
and successful road – from being a micro business to a
modern, flexible, and strong organization, supporting our
clients with the whole range of R&D services.
Clinmark is a boutique CRO, providing complete solutions
for clinical development programs, from the scientific
concept, design, execution to market authorisation. What is
unique for us is the fact that we have managed to develop
and implement proprietary methodology and tools, to easily
organise and conduct research projects in any country of the
world.
So, we can set-up and execute research project almost like a
global CRO, being more cost effective, flexible, client
oriented and friendly. We operate mainly in Europe and
Asia, but we have an evidently sound experience in US and
Africa.
Our goal is always to perform a study in the regions which
best fit that particular project. It means that we are not
attached to subjective criteria while setting up a study, but
look at it from every perspective (operational,
epidemiological, regulatory, quality, costs and of course
Sponsor suggestions and expectations).
Such an approach allows us to incredibly quickly set-up and
initiate the project. As an example, we provide first subject
in the study within 45 days from the project awarded (this is
our fastest achievement)!
The model we use very well fits any research project, but
our clients especially appreciate it when we use it to rescue
the project we are requested to take over. It took 5 years to
develop our business model, to validate and improve. It is a
totally new concept and valuable in the CRO world, and
I’m pretty sure that within few years, it will successfully
spread out together with our growth.
Tell us more about the offerings which make your
company stand out from the competition?
Our business model is based on five principles:
1. To hear our client. It is key to communicate, and to
understand the expectation and needs from one side, and
to provide the client with the objective, full picture of
projects. We are very transparent in our work, and
prefer model, in which client knows everything about
the project.
2. Operational excellence meaning that we are experts and
do our work professionally
3. Simplicity. The clinical studies are complex by nature
and regulations. We make them as simple as possible by
avoiding bureaucracy, bottlenecks, unnecessary
operations.
4. Quality. This is our blood – an integral part of Clinmark.
I’m personally an ISO 9001 auditor by training and
experience. So, quality has been and always will be a
part of our company culture.
5. Flexibility plus the ease to cooperate. We are known for
being very easy to work with. This is our philosophy and
is evident in our business model.
In addition, because we have a wise business structure, we
are a very flexible and scalable company.
What is your opinion on the impact of the current
pandemic on the global pharmaceutical sector, and what
10 Most Reliable CRO's to Watch in 2021

,,
Clinmark is lucky to have
the right people with
passion and interesting
personalities.

challenges did you face during the initial phase of the
pandemic?
The pandemic affected all the world and all businesses. For
some it was lethal, for some it was less impactful, and
miniscule for a few sectors. The pharmaceutical industry is
quite resistant to crisis, as it is about people’s health,
diseases, and problems. But R&D is slightly different, as it
is sensitive for a delay. The ongoing projects must go on, as
it is for patient safety.
Clinmark fortunately is a modern and flexible organisation,
with expert top management staff. So, the pandemic time
has passed quite smoothly. I can even say that it has enabled
us to implement solutions which we had been thinking
before for some time. So overall, I see the pandemic as an
opportunity, and we have exited it stronger.
With continuous development in technologies such as AI
and big data, what is your prediction about the future of
the pharma sector pertaining to contract research and
consulting?
New technologies, like big data, AI are a revolution for the
world. I think that this is a breakthrough almost the same as
first flight of the Wright Brothers in 1908. The aircrafts
have changed the lifestyle, business models, and human
lives. The same happens now with digitalisation of the
world. We should be happy and excited to be a part of it.
I’m personally a very tech savvy person, fascinated by the
technology world, so I’m crossing fingers for its growth.
As an established leader, what would be your advice to
the budding entrepreneurs and enthusiasts aspiring to
venture into the contract research niche?
Enter it. It is a fascinating, prospective, and a stable
business. But not the easiest, especially at the beginning.
Like everywhere, there are challenges sometimes. But if
you know the directions and have the right people around,
for sure you will be successful.
How do you envision scaling your company’s operations
and offerings in 2022?
Last year, Clinmark was awarded Most Inspiring Company
of 2020. In 2019 our project management capabilities were
acknowledged; we were nominated by Pharma Tech
Outlook as a top 10 Clinical Trial Management CROs in
Europe.
We are continuously growing, year by year. This year, as
the pandemic has stabilised, Clinmark plans to widely
develop its business model, and expand its operational
capabilities. If everything goes well in one year, we will be
in a different place than today, with double of the current
revenue.
Meet the Team
A company, and in particular the Contract Research
Organisation, cannot exist without its people. They are like
the blood of the organisation, which carries oxygen and
vitamins, but may also carry toxins. The right people can
inspire you and direct to success and will carry you through
crisis. Clinmark is lucky to have the right people with
passion and interesting personalities.
Here’s what the leadership team has to say about their
journey in the industry through their role at Clinmark:
Marek Wasiluk, Chief Executive Officer: It is always
difficult to talk about myself. My whole life is driven by
passion and curiosity. I have been doing many things in my
professional carrier, I’m DMD by education, graduated
MBA, accomplished 3 other post-graduate studies, and a
trained ISO 9001 lead auditor. I’ve been in the clinical
research industry since 1999. I love what I’m doing, and
Clinmark is not only my baby, but also my love.
Grzegorz Pogorzelski, Chief Strategy Officer: I started
my carrier as a Medical Doctor working as a physician at
one of the regional hospitals. Upon discovering clinical
research studies, I decided to change my professional path
and be a part of this world. A lot of challenges, different
duties and inspirations filled up my professional life. I
assumed this was my destiny. However, when I met Marek
and joined Clinmark 6 years ago, unexpectedly new doors
have opened. Till this day, it is still a fantastic ride with
possibility to create unique masterpieces and generate
synergy.
Jacek Banach, Head of Business Development: I met
Marek during one of the consulting meetings I gave at that
time. It was over 7 years ago. Thanks to Marek, the global
approach and trust that he gave me, I successfully expanded
my passion to connect with professionals from all around
the word, delivering unique solutions to the sponsors as the
Head of Business Development. Working in clinical trials in
international ecosystem gives me fulfilment and the feeling
that working together we can improve health around the
world. With an opportunity to have fantastic people around,
we are building something exciting, having not only
satisfaction but also fun.

,,
We are known for being
very easy to work with.
This is our philosophy
and is evident in our
business model.

Transforming the CRO Services with Diligence
Not more than a decade ago,
Contract Research Organisa-
tions were known only for
conducting clinical trials and lab
services. It has now evolved to cater to
broader service areas like data
analytics, drug development, and the
like.
Increasing investment by pharmaceuti-
cal companies for research and
development, the rising number of
clinical trials and increase in rare
diseases have led to the growth of
CRO. Globalization and technological
advances in the medical field have
added to the impetus.
CROs are known for efficient
deliverance in clinical trial manage-
ment services for pharmaceutical,
biotech and medical device companies.
The Covid-19 pandemic has seen more
pharmaceutical companies associate
with CROs for R&D and this market is
only expected to grow. As per recent
research, the CRO market is projected
to grow at a compound annual growth
rate of more than 10 % by 2026.
One CRO that has been making waves
in the market for its clinical and
regulatory development is the Switzer-
land-based 1MED. It provides all the
services that are required for the
research and development of medical
devices. It also offers post-market
assistance.
Enrico Perfler, CEO of 1MED, shared
his cognizance of the biotechnology
and medical sector in the following
interview.
Please brief our audience about
1MED, its mission, and the key
aspects of its stronghold within the
contract research niche.
1MED is a CRO focused on assisting
medical device companies in facing the
complexity associated with the
development of medical devices in
compliance with MDR by providing
support from a strategic, regulatory,
quality, and clinical point of view, with
a cross-functional approach.
1MED services can encompass all
phases of the medical device
development lifecycle, starting from
pre-clinical phases (device concept,
device design, and prototyping, bench
testing, etc.), through clinical phases
(first-in-human studies, pivotal studies,
etc.) to post-market activities to
monitor device safety and performance
when used in real-world (market
surveillance and vigilance, post-market
clinical follow-up, etc.).
1MED mission, especially towards
SMEs, is training them to ensure a
clear understanding of regulatory
requirements and their implications,
assisting them, and partnering with
them to develop sustainable products
against the industry’s constraints,
mainly identified as the time to market
and funds required for thorough
development.
1MED thrives on working with
companies that value innovation and
want to make an impact and a
difference in setting patient’s clinical
needs at the centre of their innovation.
In 2020, we were listed among the
TOP 10 consulting service companies
in Europe by PharmaTech Outlook.
But the most important recognition for
us is the trust we have been capable of
building with our clients and with the
hospitals and private institutions we
collaborate to develop innovative
products.
16|September 2021|www.insightscare.com

Enrico Perer
CEO
1Med in 10 Most Reliable CRO's to Watch in 2021
About the leader
Founder and CEO of 1MED,
Enrico Perfler, has over 15 years
of consolidated expertise in the
MedTech industry. His
recognized competence in
regulatory affairs is proven by
his active participation in
regulatory working groups at
national and international levels.
Enrico Perfler is a serial
entrepreneur who has founded,
managed, and invested in
several MedTech start-up
companies. He is also an author
of internationally granted
patents for cardiovascular
medical devices and in-vitro
tissue engineered models.

Tell us more about the offerings
which make 1MED stand out from
the competition?
1MED was born to create a Contract
Research Organization able to talk on a
technical level with medical device
manufacturers and to fully understand
the technologies that lie behind the
product itself.
Working with international and start-up
companies on new product
developments and interacting with EU
Competent Authorities and Notified
Bodies allowed us to understand that,
often, hurtles during the approval
processes for innovative medical
devices are mainly due to the lack of
understanding of the technology and of
the benefit that such technology, in the
end, may have for patients.
Our approach allowed us to support the
certification of more than 300 different
medical devices with a success rate of
100% in the last seven years.
What is your opinion on the impact
of the current pandemic on the
global CRO vertical, and what
challenges did 1MED face during the
initial phase of the pandemic?
COVID-19 pandemic changed multiple
aspects of our life; one of these was
limited access to healthcare institutions
for non-COVID-19 patients. This
caused a drop in emergency
department visits, hospitalizations, and
delay in surgeries for a considerable
number of patients.
As a consequence, there was a halt in
patient enrolment in most of the
clinical trials that were non-COVID-19
related. Also, ordinary activities with
clinical sites (e.g., qualification visits
or monitoring visits) were significantly
reduced.
With continuous development in
technologies such as AI and big data,
what is your prediction about the
future of the CRO vertical?
Recent European Regulations require
medical device manufacturers to
generate clinical data not only in the
pre-market phase for obtaining market
clearance (i.e., CE-mark) but also in
the post-market phase to confirm their
product's risk/benefit profile for
certification maintenance.
In this regard, real-world data is a key
and digital solution based on machine
learning, big data are helpful for
analysing a huge quantity of data.
1MED is investing in digitalization and
artificial intelligence by developing IT
tools to capture clinical data and
simplify its management.
As an established leader, what would
be your advice to the budding
entrepreneurs and enthusiasts
aspiring to venture into the contract
research niche?
Both as market trends and regulation-
wise, patient’s benefit is becoming the
core of the innovation: research and
development of new medical devices
should only have a positive impact on
patient’s benefit concerning the
standard of care, setting profits, not as
the main push for innovation.
All stakeholders of the MedTech
industry have to become more aware of
the ongoing paradigm shift that puts
the patient at the centre. The most
important message that I would like to
convey is that the research and
development of new medical
technologies in the future should be
socially and economically sustainable.
Only effective products will be allowed
to enter the market, adding value to the
supply chain. If products are effective,
this also reflects on the national
healthcare system, which will be able
to guarantee better, faster, and more
cost-effective cures with a lower
overall impact on the costs of the given
treatments, also reducing overall
hospitalization rates.
How do you envision scaling 1MED’s
operations and offerings in 2022?
To be competitive and to fulfil patient’s
needs, in this dynamic industry, we
always need to be up to date and very
well trained about ongoing main issues
and topics that come up daily. 1MED is
reinforcing its MDR and IVDR team to
satisfy the increased demand for
clinical studies and regulatory services.
At the same time, the development of
proprietary IT tools for clinical study
management and real-world data
analysis is key for supporting our
growth as well as the acquisition of
strategic target companies to accelerate
our market penetration in Europe.
1MED is inves ng
in digitaliza on
and ar ficial
intelligence by
developing IT Tools
to capture clinical
data and simplify
its managment.

After the outbreak of the pandemic, companies
rushed to find a medicine that could cure the
infected people. Along with being a time taking
process, it was also highly costly. This affected the
pharmaceutical industries and biotechnology industries at
the max. Pharmaceutical companies are often at bay
regarding the size of the industries, but the biotechnology
space is relatively small and just could not handle every-
thing.
This is where CRO or Contract Research Organizations
came into the picture—helping these industries in the R&D
process. Let us assume a hypothetical situation where a
similar outbreak of COVID-19 occurs; being in the
biotechnology industry, it becomes your responsibility to
find the drug for the cure.
Looking at the statistics, it takes approximately $2.6 billion
to develop a new drug, which is indeed a huge amount of
money for a biotech company to invest. Apart from that,
only 12% of the new drugs are approved by the U.S. Food
and Drug Administration (FDA), which narrows down the
chances of the success of the drug. Since you, as the
biotechnology industry alone, cannot oversee everything,
outsourcing CRO in the development is the way to go.
Moreover, despite being a conjugal force, the biotech
industry and CRO have recently become the standard. Here
is how CRO help the biotech industry:
Filling the gap of resources
Biotech companies lack resources; the inclusion of these
companies with CRO fills this gap, helping the companies
in research and development. Earlier biotech companies
hardly made it to Phase I of the clinical trials, but due to the
lack of resources, they could not proceed with the later
stages. This forced the companies to merge or take support
of large pharmaceutical companies.
To maintain ownership and fill the gap of resources, CRO
makes the process easy and efficient for biotech companies.
Along with that, CRO usually has a wide network, which
helps the company with the research, which is often
effective and to the point.

Expenditure Reduction
For small and even large biotechnology companies, not
every investment is a promising investment. One such
similar case is with the investment in the infrastructure of
Research and Development. This makes the entire process
costly because, along with the manufacturing, the company
also has to fund the research and manage the cash flow
efficiently. However, outsourcing CRO comes with
numerous advantages like increasing the efficiency of drug
testing, boosting the success rate and accelerating the drug
discovery process.
Cost Cutting
Biotechnology is a costly industry. Though the profits will
recover the expenditure, investing in such a complicated
process can often result in losses. CRO brings flexibility
and versatility to the company. Helping the company in
different sectors like research, development, and delivery to
the market makes the complete process much cheaper.
Usually, boosting the process of clinical trials makes the
trials much economical. The boost in the success rate also
adds to the cost-cutting.
Completing the Cycle
The biotech industry is heavily relying on CRO in the
current market scenario. CROs today are providing all the
necessary things required in the biotech industry. Starting
right from the market research to the final drug approval,
CROs are making a huge difference in the success rate of
biotech companies. CRO has reduced the time to market for
the drug. Despite being an outsourcing industry, it has all
the required infrastructure and skills required for the
biotech companies to provide critical and high-priority
service effectively and efficiently.
Having all the resources and a wide network spread
worldwide, it becomes easy for the companies to bring out
the drug early in the market. The services provided by these
CROs vary from project and data management, Quality
analysis, Research, Execution, Medicine and Disease
Coding, Safety Reporting, Medical Writing, Regulatory
Support, etc. With the inclusion of all these services, CRO
completes the cycle with efficiency for the biotech industry.
The risk of failure is always going to be there for biotech-
nology industries, despite working side by side with CRO.
Also, the inclusion of a better outsourcing option from the
market doesn’t need to guarantee success. A biotechnology
company must consider all the required factors before
hiring any CRO. Along with such factors, time and resource
management while working alongside CRO must be
considered. The other alternative for biotech companies has
been to hire and train people for the job.
CRO and the biotechnology industry are highly dependent
on one another for the efficiency that they provide. Along
with the increased profits, the venture of both the industries
marks a differentiating point in the market covering, which
makes the product successful, proving the effectiveness of
the biotech industry.
- Ashlesh Khadse

Enabling Proficient Clinical Trials for Healthcare Service Providers
C
linical trials have a huge
significance in the healthcare
sector as it enables researchers
and pharmaceutical companies to
develop drugs and medicines that bring
revolutionary changes enhancing and
empowering healthcare to improve
quality of life.
While pharmaceutical companies have
always relied on companies carrying
out clinical trials, few have made a
mark by delivering high-quality
results, and Biorasi is one of them.
Led by Chris O’Brien, CEO with his
passion for technology and diligence in
delivering consistency, Biorasi has
proved itself apart from the
competitors through the company’s
focus on quality and responsiveness.
In the following interview, Chris shares
more about the company’s operations
and approach towards its sponsors, the
effect of the ongoing pandemic on the
business as well as his plans for the
company moving forward in the post-
pandemic era.
Biorasi, its mission, and the key
At Biorasi, we work with sponsors to
deliver effective clinical trials for rare
We believe execution is everything in
clinical trials, and we focus on
delivering high-quality results faster.
“ “
Chris O’Brien | CEO

diseases, oncology, and other urgent
conditions. We believe execution is
everything in clinical trials, and we
focus on delivering high-quality results
faster. Our speed and responsiveness
differentiate us from larger CROs, and
our focus on quality (including our
recent achievement of ISO 9001-2015
certification) differentiates us from the
competitors.
which make your company stand out
from the competition?
Sponsors tell us they value our
transparency and our commitment to
partnership. We achieve the first
through technology, we synthesize
Biorasi data as well as data from third
parties to give sponsors real-time
insight into the study. Sponsors feel the
commitment of the Biorasi team
because that team is not spread across
a dozen studies. Our dedicated teams
make the sponsor a top priority.
Chris, please brief us about your
journey in the industry.
I’m the CEO of Biorasi. I’m passionate
about applying technology and process
consistency to service businesses. The
biggest players in the CRO industry
have grown through acquisition,
resulting in some very complicated and
inefficient companies that mash
together conflicting systems, processes,
and cultures. We believe sponsors
deserve better.
challenges did your company face
during the initial phase of the
pandemic?
The industry is experiencing 10 years
of change compressed into one year.
During the pandemic, we first pivoted
to remote operations and remote
management of our sites. Then we
build out our decentralized trial model.
The key here is not anyone’s
technology but the synthesis of that
technology into efficient processes and
the memorialization of this in well-
designed SOPs. The real value lies at
the intersection of process and
technology.
Advanced analytics are already playing
a role in data hygiene and in-patient
identification in clinical trials. We see
that role expanding, but you have to be
a skeptical consumer. Because AI is
both a hot term and an ill-defined one,
we’re seeing plenty of companies slap
an AI descriptor onto their systems.
Awards and Accolades
Named as ‘Entrepreneurial Company of 2020’ in
the Clinical Research segment by Frost and
Sullivan.
Entered the list of Inc 5000 last year for fastest-
growing companies.
ISO 9001-2015 certification, an achievement that is
very rare in the CRO world and which speaks to the
commitment to quality.
research niche?
Understand good clinical practice and
the regulatory requirements that are
essential for clinical research. We see
plenty of health-tech companies that
focus more on tech and less on health.
You want to build data privacy, 21
CFR Part 11 compliance, etc. from the
beginning.
How do you envision scaling your
company’s operations and offerings
in 2022?
The biggest challenge today is
attracting and retaining great people.
The way to do that is to make Biorasi a
great place to work. We’re very
focused on that.

An Inventive Approach of Designing and Performing Clinical Trials
C
ontract research organizations are emerging as
important partners for pharmaceutical and
biotechnology companies to conduct clinical
research. But with several CROs mushrooming in the
market, the pharmaceutical and biotechnology companies
are at times confused as to which suits them the best.
For pharmaceutical and biotechnology companies, CROs
have become exceptionally valuable partners, specifically
for the progress of new drugs. As there are several CRO’s
vying in the market, the most prevalent issues arise:
What are the most trending updates within the contract
research niche for Pharmaceutical and Biotechnology to be
aware of? Which will be the most suited option to select
among so many? And according to their priorities, what are
the cursors to be looked at?
In this edition by Insights Success, “10 Most Reliable
CRO’s to Watch in 2021” we will acme the excellence of
these CRO’s that make them the top ten most reliable CROs
for you to be affiliated with.
In our aspired search of the foremost CRO’s, we came
across contract research organization
Pivotal S.L.U. It is a
that offers a variety of contracting models, from a single
source to full service in the chain of drug development
activities, from start-up to completion of the corresponding
final study report.
Pivotal’s scientific team provides risk-management
strategies for their client's products to make it the most
brilliant choice in the market. In the following interview,
Dr. Ibrahim Farr, Chairman and CEO of Pivotal S. L.U.
uncovers about the company’s journey about how it has
developed into one of the premier CROs and his opinions
about the market that their company serves.
Please brief our audience about your company, its
mission, and the key aspects of its stronghold within the
Pivotal was founded back in November 2001 by Dr.
Ibrahim Farr– with the ambition to become a full-service
and therapeutically focused CRO. It has been permanently
operating for almost 20 years, on the principle that strategic
medical advice and support should be the backbone of all
clinical trials.
It was recognized since then as an EU-CRO with a solid
internal medical franchise, that could act as co-thinkers for
our clients and not merely as ‘doers’. It has been providing
tactical as well strategic advice in the Clinical Trials
landscape.
Today, it is headquartered in Madrid and is legally
incorporated. It has provided services in >22 countries
,,
,
,
All in all, we are learning
fast and have the wish
and commitment to walk
with the times and offer
our clients modern
accurate solutions for
their projects.

About Dr. Ibrahim Farr
Dr. Farr is MD by training and specialist in
psychiatry and pharmaceutical medicine. And
has brought Pivotal thirty years of experience in
drug development. He has worked in companies
like – Marion Merrell Dow, Cyanamid/Wyeth, and
Rhone-Poulenc Rorer/Aventis.
Dr. Farr has devoted his life to clinical research
and drug development from both the Pharma
and the CRO side.
It is the result of spending years in managing
clinical research for the Pharma sector, and
thanks to his scientically driven mind that he
realized how important it was to count on solid
strategic medical advice and support as the
backbone of all clinical trials.
Then he jumped out of Pharma and transited to
the CRO side as he founded his own company
‘Pivotal’, with a purpose in mind, to not merely
activate and conduct trials, but also ‘think the
trials’ for and with the clients themselves while
walking with them hand in hand all the way
down.
across Europe. We count on Pivotal’s staff proper in most of
these countries.
Our goal was then and still is to provide our clients with
high-quality services across the value chain of drug
development activities, from start-up to completion of the
corresponding final study report.
Although Pivotal is an EU-focused CRO we do have solid
established and well tried and tested partners in the US,
Asia Pac and SA.
We are a full-service organization covering all tasks needed
in drug development, with a strong medical and scientific
focus and across all therapeutic areas. Major services
provided within our services portfolio are:
Regulatory affairs and study start-up, clinical trial
monitoring and sites/projects management, data
management and biostatistics, medical monitoring, PVG
services, quality assurance and auditing, biotech
consultancy, and patient journey services.
We have been awarded to face and succeed in all projects.
Pivotal counts with an energetic, long-experienced, client-
oriented and committed personnel, always seamlessly
pushing forward to drive our clients’ trials and studies to the
right place.
Pivotal is proud to offer all its clients highly customized
teams that bring a combination of broad industry
knowledge and operational excellence that allow us, in turn,
to offer our clients fresh perspectives and breakthrough
business insights.
Lastly, we want to stress that we are committed to new
technologies and challenges and are on the way to promptly
make a shift to – or at least also offer - the possibility of
designing, conducting, and managing that new kind of
virtual clinical trials with all their new specific requirements
and demands. We will not lag.
Tell us more about the offerings which make your
company stand out from the competition?
Below are, in short, major reasons why we think Pivotal
may be a preferred option for several companies, which are
looking for a CRO to partner with when planning to set up
and conduct a clinical study:

• Client-oriented approach: Our senior management is
approachable and directly involved in the clinical studies.
Our operational team is energetic, client-oriented, and
deeply knowledgeable
• Full-service solution
• Therapeutic focus across many areas
• Cost-effective solution
• Scientific expertise with the internal medical division
staffed our medics, specialists in several areas like -
oncology, hematology, clinical immunology, cardiology,
internal medicine, CNS, and more. And will be the
backbone of the trial by bringing in-depth therapeutic
expertise and strategic advice
• Geographical reach across Europe with solid partners in
the US, Asia Pac and SA
• One-team attitude, integrity, and commitment
What is your opinion on the impact of the current
pandemic on the global CRO vertical, and what
challenges did your company face during the initial
phase of the pandemic?
Challenges have been felt and encountered by all CROs
while providing clinical research and services to those
Pharmas and Biotechs like Pivotal did throughout the
pandemic.
Nevertheless, we consider the pandemic a good opportunity
to streamline processes as well as bring to life a new
methodology for drug development.
New technologies on one hand, and the COVID-19
pandemic on the other, are demanding us to re-think the old
in-house procedures. For example, no paper anymore and
imposing the learning of how to manage trials involving the
use of those new technologies, and which walk close
together with the handling of clinical trials from a new
‘virtual’ or ‘decentralized’ perspective.
And these are likely the most defiant challenges long track-
record CROs like Pivotal will have to deal with rapidly. At
Pivotal, we understand all these demands and are
committed to new thinking paradigms and technologies.
The COVID-19 pandemic has forced Pivotal to adopt new
working ‘remote’ scenarios, and although many of our
studies have been impacted by COVID-19 and none have
been particularly delayed or cancelled because of this.
With continuous development in technologies such as AI

and big data, what is your prediction about the future of
the CRO vertical?
Today, we have done enough research on the same and have
worked towards removing paper from most of our
procedures. We have even developed a proper internal bred
cloud-based trial tracking system called ‘Danah’, which
includes solutions to create robust and reliable tracking
systems and eTMFs.
All in all, we are learning fast and have the wish and
commitment to walk with the times and offer our clients
modern accurate solutions for their projects. We are ready
to rapidly assist our clients to shift to this new environment
by leveraging all newly available tools.
As an established leader, what would be your advice to
the budding entrepreneurs and enthusiasts aspiring to
venture into the contract research niche?
The first piece of advice is that an entrepreneur venturing
into this industry should be scientifically and quality
minded. Secondly, he/she should focus on delivering high-
quality work to help bring new medications to the clinic, to
address the unmet medical needs of many patients and
support the advancement of Medicine.
Leadership by example is a must in our industry, hence, the
third piece of advice is that the leader´s involvement in the
day-to-day work is essential to evolve the firm and produce
the desired growth and that he/she should be the face of the
company for the client.
How do you envision scaling your company’s operations
and offerings in 2022?
Much of the story discussed in previous sections has to do
with the expected coming of a new way of planning and
conducting clinical trials. Certainly, CROs will have to
adopt these new requirements and learn how to play in the
new virtual scenario but ancient typical problems of clinical
trials will still be there.
And we believe that one of the most important hurdles in all
R&D work has always been and will be patient recruitment.
Strategies to optimize enrollment shall always be
considered as these may enormously help to warrant that
target figures to provide robust and sound scientific
conclusions are met and to help control the budget of the
project when enrollment issues are noticed too late. This
will help in the prevention of incurring additional costs.
At Pivotal, we are quite conscious of how lack of adequate
enrollment may impact the trials of our clients and hence
Pivotal has recently acquired and rebranded as Pivotal
Patient Journey, an independent EU-based company
focused on accelerating patients and healthy volunteers'
recruitment within Europe and the US.
Therefore, with the aim to improve patient outcomes
always in mind, we have developed and embraced patient-
centric thinking. And our patient-centered services leverage
the patient´s perspective to enhance awareness, recruitment,
and retention. C-Lys is our cloud-based patient management
platform, fully customizable to your studies, which may
provide a range of automation and survey solutions to
efficiently manage patient recruitment.
Pivotal has adhered to the Alliance for
Children´s Vaccination as well as other
NGOs in the area. Pivotal collaborate
along with Gavi, an international
organization and Global Vaccine Alliance, in
the ght against children’s mortality in
the world’s poorest countries. Pivotal has
been selected as one of the few rms that
attracted recognition from the Pharma IQ
network as a ‘RISING STAR’.
This survey was performed independently
by Pharma IQ among their international
community members who were asked to
nominate CROs for 2018, which they
recognized as the leading and the best in
the pharmaceutical and biologics industry
based on their own experiences.
The research base was made up of
international participants from mainly big
pharma or biotech, SME pharma and
consultants, government bodies, medical
device manufacturers and public hospitals.
The above is just a sample of the awards
and recognitions received, which are very
much related to our client's continued
condence and trust in Pivotal as their
valued partner in clinical research and the
quality of services Pivotal provides across
a broad spectrum of clinical trials and
therapeutic areas.

Humans have come a long way from relying on an
old man for medical treatment to keeping track of
their health by simply wearing a watch. Earlier, a
man had to depend on big machines to get that essential
data to tell their health condition. The processing of this
data would take days, which today is just a matter of a few
hours. This is all because of the medical technology that is
still upgrading and making a difference in our lives.
Innovations and advancements in technology lead to the
foundation of medical technology. However, the need for
medical technology was felt because of the ineffectiveness
of humans in treating complex conditions. The global
scenario back then also demanded the need for equipment
and machines that could assist doctors. Looking back at the
history of medical technology, it developed with simple
tools like the flexible catheter, which was developed by
Benjamin Franklin and his brother in 1751.

To know what we have today, we need to know what we
had in the early days. The evolution of medical technology
existed from the time humans started to study anatomy.
However, the required boost that medical technology
needed came in the 19th century, and since then, there has
been no looking back. To uncover the important events,
let’s cover the major technological advancements in each
century’s healthcare field.
19th Century: Invention of the symbol of the medical
profession
When you hear the word ‘doctor,’ instantly, a picture of a
man in a white coat and a stethoscope around his neck
appears. Did you know that the medical profession’s
signature or symbol was invented in 1851? Rene Laennec
invented the stethoscope because he could not hear his
patient’s heartbeat by placing his ear on her chest. Though it
was made up of wood and looked like a trumpet, it has
surely come a long way since then to become a symbol of
the medical profession.
Twenty-three years later, in 1874, a British scientist named
Richard Caton used a galvanometer to determine electric
impulses in the brain of animals. This theory was later used
in the development of ECG, which is commonly used in
medical practice today. However, a still in practice drug
used during surgery to minimize pain, anesthesia, was used
prior to these inventions. Dating back somewhere in 1841,
Crawford Long used diethyl ether as anesthesia to remove a
part of the tumor around the neck region of his patient. All
these discoveries and inventions triggered the need for
medical advancements.
20th Century: Setting the Benchmark for Medical
Technology
The trigger set in the earlier century was carried on to the
20th with many inventions and discoveries. However, one
of the benchmark inventions of the 20th century came in the
year 1903, when Dr. W. Einthoven, a Dutch scientist,
developed an electrocardiogram. Though the equipment
was huge in the early days, it is still one of the fastest and
simplest tests to evaluate the heart.
The next benchmark evolution in medical technology came
in the year 1971 when Dr. G. Hounsfield developed the first
Computed Tomography scanner. It was clear by then that
the arrival of computer technology was going to transform
the whole healthcare industry, and soon after that, in the
year 1978, Dr. Raymond Damadian discovered a technique
of Nuclear Magnetic Resonance, which was used to
differentiate normal cells and cancer cells. The advanced
development in this technique was later used to develop
MRI.
21st Century: Advance Medical Technology and the
Current Scenario
The century started with the announcement of a landmark
project in the field of medical technology. The research on
Human Genome Project was started in the year 2000 and
completed in the year 2003. It is because of this project that
we acquired in-depth knowledge about human DNA. Soon
the medical technology developed so much that a year later,
the first prosthetic joint was invented. The artificial knee,
elbow, or forearm made up of plastic allowed the users to
adapt and freely use their body parts. This allowed the
impaired patients to move their joints freely.
The advancement in medical technology was boosted as
computers became more common and allowed flexibility in
research. Soon in the year 2006, two scientists developed
stem cells to create a functional liver. Though the liver was
not implanted in any humans because of the size, the
application and use of stem cells proved to be significant in
later years for research.
It was in this century that mankind saw a rise in medical
technology. In the current COVID-19 pandemic scenario,
due to the advancements, the time taken for the
development of the vaccine was cut down to one year from
four years. Along with that, the healthcare industry
transformed itself with the application of Artificial
Intelligence and Machine Learning. The introduction of
wearable devices allows users to keep track of their health
conditions.
This is how the medical industry has transformed over the
years, providing humans with an effective and reliable
healthcare system along with the flexibility in maintaining
and tracking our health conditions.
-Ashlesh Khadse

Regulating Essential Clinical Trials and
Observational Studies
The recent pandemic made the
whole world realize the
significance of clinical
research. The CRO industry was one of
the sectors that was in focus during the
COVID-19 pandemic to conduct
vigorous clinical trials for producing
an effective vaccine to combat the
coronavirus.
In doing so, CROs had to consider the
various processes that went into
developing an efficient vaccine, which
would help battle the lethal virus.
Sofpromed is one of the leading CROs
that specializes in the global
management of phase I-IV clinical
trials worldwide for biotechnology and
pharmaceutical companies.
In the following interview, Patricio
Ledesma, the General Manager
elaborates on how the company is
making an effective contribution in the
healthcare space, the challenges that
the company came across, and his
vision for the company’s future.
Sofpromed, its mission, and the key
We are a full-service clinical research
organization (CRO) specialized in
managing phase I-IV clinical trials in
oncology for biotechnology and
pharmaceutical companies worldwide.
The company was founded in 2012 and
offers a one-stop approach including
regulatory, clinical operations, data
management, and statistical
programming capabilities to manage
cancer trials from beginning to end.
which make Sofpromed stand out
from the competition?
Our key differentiator is a long-
standing expertise in managing
oncology clinical trials including less
frequent tumors such as sarcomas, and
rare gynecological and pediatric
malignancies, among others. Through
our deep knowledge of the rare tumor
space and our already established
network of high-volume cancer centers
across Europe and the United States,
we are able to offer effective clinical
site selection and fast patient
recruitment for sponsors developing
anticancer therapies, in both early
phase and late-stage studies.
challenges did Sofpromed face
during the initial phase of the
pandemic?
The appearance of the pandemic had a
favourable business impact on those
CROs that were awarded to manage
COVID-19 clinical trials. During the
high peaks of the pandemic, the
number of coronavirus clinical studies
initiated around the world increased
massively, substantially augmenting
the workload of CROs managing these
types of studies.
On the other hand, the abrupt rise of
COVID-19 studies at clinical sites
affected the staff and technical
resources dedicated to clinical trials in
other therapeutic areas. During the
initial phase of the pandemic,
Sofpromed, as a CRO specialized in
oncology, observed how cancer patient
recruitment slowed down across all
studies, and how patient management
quality was diminished due to lack of
internal resources at sites, restricted
access, and less hospital visits.
The application of new technologies,
such as AI and big data, to clinical
trials are already key value and
leadership drivers in the CRO market.
Being a technology driven CRO is not
an option anymore. Data-based clinical

Patricio Ledesma, Sofpromed’s
Founder and General Manager,
accumulates more than 15 years
of experience in the cancer
clinical research sector, with wide
expertise in leading clinical
operation teams in both
academic and commercial clinical
trials.
Through the years, he has
established strategic
collaborations with academic
cancer research groups and
international key opinion leaders,
facilitating the effective
implementation of multinational
clinical studies. He is devoted to
helping biotech companies in the
planning and execution of phase
I-IV clinical trials across North
America, Europe, and Asia-Pacific.
About the Leader
Being a
technology driven
CRO is not an
option anymore.
Data-based clinical
trial simulation
can be useful to
improve inclusion
criteria.
trial simulation can be useful to
improve inclusion criteria.
Leading CROs are already adopting AI
tools in their workflows. Data analytics
provides tremendously valuable
information that can improve site
selection, recruitment rates, and
eventually patient outcomes.
Therefore, CROs will need to step into
these tools to take their offerings to the
next level.
research niche?
The clinical trial management sector is
an exciting world full of opportunity.
Although the CRO industry is led by
big multinational players, there is and
there will always be abundant market
opportunity for small-sized, emerging
CROs, which are able to offer value to
clinical trial sponsors in general, and to
small biotech in particular.
As in other businesses, technical
capacity and customer care are
essential, but especially in the CRO
space, operational flexibility and
responsiveness towards the client
makes a world of difference. My main
advice for an entrepreneur aspiring to
venture into a CRO business would be
ensuring a good service and really care
for the needs and problems of your
clients.
How do you envision on scaling
Sofpromed’s operations and
offerings in 2022?
After 10 years of its foundation,
Sofpromed has experienced quick
growth in recent months, as the
company is rapidly expanding its
biotech customer base dedicated to
executing international phase II and III
clinical trials across Europe and the
U.S. The company has an exciting
perspective to continue with its organic
growth through an increased presence
in the U.S. market and the provision of
state-of-the-art clinical data
management and statistical
programming services.

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