THE CHALLENGEOF DIGITAL TRANSFORMATION IN THE LIFE SCIENCES SECTOR

Virginie GROSSO Associate General Manager France & Delivery Director | Keyrus Life Science

Brigitte MARCHETERRE General Manager Canada & USA | Keyrus Life Science

E X P E R T O P I N I O N

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The immediate advantage of digital technologies in this

context is the access they provide to an incredibly rich

pool of information. This improves decision-making regar-

ding the efficiency and conduct of clinical trials. Typically,

the creation of government databases of comprehensive,

anonymous, electronic medical records allows trials to be

conducted in a faster, more reliable, and – for the patients

– more personalised manner. This data also allows us to

measure the medication’s effectiveness in a real-world

situation, and the patient’s quality of life.

The second advantage concerns patient selection. Remem-

ber, 80% of clinical trials do not recruit their target number

of patients, and 50% of research centres only recruit

one patient… By developing online recruitment using

specialised platforms, we widen the net, increasing both

the quality and quantity of potential candidates.

Another use for data and digital in healthcare could be the

analysis of patient experiences shared on social media.

This indicator can be used, among other things, to enhance

trials by offering the patient’s perspective, collect real-

world data on the use of medication, and even identify

misuse and prevent health crises.

This incredible technological potential puts new responsi-

bility on CROs to drive innovation among their customers,

by combining traditional and digital expertise.

DATA, AN EXCEPTIONAL PERFORMANCE LEVER FOR CLINICAL TRIALS

R&D activity, which is essential to providing

new medications and medical treatments, is

currently under mounting pressure from increa-

sing competition and regulation. How can digital

be leveraged to combat these challenges?

Virginie Grosso, Associate General Manager

France & Delivery Director – Keyrus Life

Science, and Brigitte Marcheterre, General

Manager Canada & USA – Keyrus Life Science,

outline their vision.

R&D represents an industry pain point: cycles of 10 to

15 years, very little chance of success (the probability of

obtaining regulatory approval once a molecule has been

identified is 1 in 10,000!), the need for high numbers of pa-

tients with a suitable profile, and the increasing complexity

of clinical protocol (59% more certifications and 25% more

patient visits in 10 years), makes it difficult to recruit pa-

tients for trials.

Public authorities appear to have decreasing funds avai-

lable to invest in healthcare, despite increasing safety

requirements and an expectation for ever-more effective

medication. Now more than ever, the main challenges in

clinical trials are delays, cost and quality.

EXPERT OPINION

THE CHALLENGE OF DIGITAL TRANSFORMATIONIN THE LIFE SCIENCES SECTOR

AN INADEQUATE REGULATORY FRAMEWORK

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On the other hand, this potential is currently held back

by a legal framework that lacks clarity. AI, Big Data, smart

devices to be worn or implanted, and Blockchain as a

means of gaining trust, each raise important legal and

ethical questions. To whom does the data belong, how is

it anonymised, how do we obtain patient consent, what is

the share of responsibility between the doctor, the biotech

that developed the algorithm, the algorithm, and so on?

We are still grappling with these fundamental questions.

Virginie GROSSO

Holding a master (DESS) from Montpellier in Statistical Methods applied to the Agri-food, Agronomic,

and Pharmaceuticals Industries, she has more than 25 years' experience in the Healthcare field.

Having worked at Keyrus Life Science for 19 years, she now holds the position of Delivery Director,

managing nearly 150 people across 4 sites in France and internationally.

Brigitte MARCHETERRE

With 25 years’ experience in the pharmaceutical industry, Brigitte has developed her career within

different organisations, on the Sponsor and CRO side, consistently acquiring further managerial

responsibilities. Since 2003, Brigitte has passionately managed her own CRO, MedQualis, which

joined Keyrus Life Science in 2016, creating numerous geographic and operational synergies.

With the advent of e-health, Brigitte became particularly interested in the application of digital

solutions in clinical trial management.

ABOUT THE AUTHORS

ABOUT KEYRUS LIFE SCIENCE

Keyrus Life Science is the first C2RO (Connected-CRO), created to accelerate the Digital Transformation of Life

Science companies.

Keyrus Life Science helps connect industry expertise, Life Data Sciences and Digital Enablement to fully leverage

both Clinical Research ecosystems and Real-World Evidence/RWE in healthcare, thus enhancing the reliability,

innovative capacity, agility, and, above all, speed of execution of Clinical Research activities.

Structured around a core objective and drawing upon 20+ years of experience and covering Europe, North America

and the MEA area, Keyrus Life Science’s services cover all aspects of clinical research requirements, both current

and future:

C2RO: Regulatory affairs, Clinical operations, Data management, Statistics, Medical writing

Life Data Sciences: Real-World Data analytics, Health data insights, Smart Study Planner®, Artificial Intelligence

Digital Enablement: Digital platforms, Wearables, Digital patient recruitment, e-Health solutions

By improving data collection and quality, patient recruitment and adherence, and by making sense of extended

ecosystem data, Keyrus Life Science contributes to enhancing Clinical Research & Development practices to

promote better health!

More information at: www.keyruslifescience.com