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Therapeutic areas

Turning endpoint noise into reliable CNS trial data

NeuroscienceRater training
Go back CNS Most CNS trials don't fail because the therapy doesn't work. They fail because assessment variability buries the signal. This white paper explores how linguistic and cultural adaptation,...

Elevating rare disease clinical trials through eCOA – From patient voice to regulatory success

Rare disease
Rare disease clinical trials face a unique combination of scientific, operational, and regulatory challenges. Small patient populations, heterogeneous disease presentation,...

Overcoming rare disease trial challenges: the strategic impact of eCOA

Rare disease
Rare disease trials are crucial for addressing major unmet medical needs, yet they are among the most challenging to design...

ePRO in early phase oncology trials: A revolution on the horizon

Oncology
While the integration of Patient-Reported Outcomes (PROs) into phase IIb and III clinical trials has become increasingly widespread in the...

Patient-Reported Outcomes in early-phase oncology clinical trials
A Stepping Stone to a Patient-Centered Drug Development

Oncology
In phase I clinical trials, the recommended phase II dose (RP2D) is usually set at or near the maximum tolerated...

Gastrointestinal Tract Diseases Research: Moving Towards Patient-Centered Clinical Trials

Gastroenterology
The management of gastrointestinal tract diseases, especially inflammatory bowel disease (IBD), has been transformed over the past few decades. This...

Turning experience into evidence: PROs in IBD clinical research

Gastroenterology
Inflammatory Bowel Disease (IBD), including Crohn’s disease or Ulcerative Colitis, presents a complex and highly individualized clinical picture, making it...

If Patients Want A Better Quality Of Life, Why Isn’t That A Focus For Pharma?

OncologyPatient engagement
A conversation with Frédéric Fiteni, Ph.D., medical oncologist and oncology PRO specialist, University Hospital of Nîmes, and, member of Kayentis Scientific...

Immunology Case Study

Immuno-Inflammation
Immunology studies present specific challenges: their eCOA build can be complex, site staff must play a key role, and study...

The unquestionable value of electronic Clinical Outcome Assessments (eCOA) in rheumatoid arthritis clinical research

Immuno-Inflammation
Rheumatoid Arthritis (RA) is a common, chronic disease that causes inflammation and often presents with pain in the joints. Untreated,...

Collecting PRO data in leukemia clinical research: the only way to meaningfully improve patients’ quality of life

Oncology
The prevalence of leukemia is increasing worldwide. Chronic Myeloid Leukemia (CML) patients benefit from recently improved care but receive prolonged,...

Collecting PRO data in cancer trials: bringing the patient perspective in oncology clinical research

Oncology
As one of the biggest research area, oncology remains the focus of the clinical trials pipeline, comprising 44% of the...

Rare disease clinical research: it is time to tackle what matters most to patients

Rare disease
Supporting the development and evaluation of new treatments for rare diseases has become a key priority of the 21st century....

Rethinking pediatric clinical trials: guidelines from pediatric experts

PediatricSites perspectives
In this last episode on pediatric clinical trial challenges, Begoña Nafria, pediatrician and patient engagement lead at SJD Barcelona Children’s...

Overcoming challenges in long-lasting pediatric clinical trials – Insights from site experts

PediatricSites perspectives
In this third episode on pediatric clinical trial challenges, Begoña Nafria, pediatrician and patient engagement lead at SJD Barcelona Children’s...

Tackling the specificities of NASH/MASH clinical trials

Metabolic
Integrating PROs into studies on MASH, also known as NASH, is crucial. MASH is a debilitating chronic illness that significantly impairs...

Mastering pediatric asthma clinical trials

PediatricRespiratory
Asthma clinical trials present several specificities, such as the use of disease-specific health-related quality of life instruments. Asthma clinical research...

The importance of ePRO to support NASH/NAFLD unmet clinical research and medical needs

MetabolicScientific advice
NonAlcoholic SteatoHepatitis (NASH), now called Metabolic Dysfunction-Associated SteatoHepatitis (MASH), affects almost 115 million adults globally and is the most severe...

How DCTs Can Help Pediatric Clinical Research – Insights From Site Experts

PediatricSites perspectives
In this second episode on pediatric clinical trial challenges, Begoña Nafria, pediatrician and patient engagement lead at SJD Barcelona Children’s...

Ophthalmology Clinical Trials

Ophthalmology
Ophthalmic conditions and vision impairment currently affect 2.2 billion people globally: Data collection can be very challenging for patients with...

Innovation and Partnerships: The Biotech Perspective

biotechCardiology
In the ever-evolving landscape of biotechnology, groundbreaking advancements continue to shape the future of healthcare. In this exclusive interview, Estelle...

Exploring The Specific Challenges Of Pediatric Clinical Trials – Insights From Site Experts

PediatricSites perspectives
In this first episode on pediatric clinical trial challenges, Begoña Nafria, pediatrician and patient engagement lead at SJD Barcelona Children’s...

Implementing electronic Patient Reported Outcomes (ePROs) in Arthritis Clinical Research: Importance, benefits, and management for incorporating ePROs

Immuno-Inflammation
Arthritis is a general term categorized by acute or chronic inflammation of the joints. Arthritis may cause a variety of...

Working with patient associations: What is the key to a positive interaction?

Patients insightsRare disease
What rare disease patients and families want is a simpler life. Discover here what makes the relationship between the members of...

How a patient association gave rise to a company

Patients insightsRare disease
A patient association in rare diseases is first and foremost families who all have one thing in common: they need...

Direct insights from cancer patients: How they help us understand disease burden and the need for an individualized approach

OncologyPatients insights
Cultural differences and individual preferences have a significant impact on healthcare and clinical trial experience. Solutions exist in attempt to...

Rare Disease case study

Rare disease
Over 90% of rare diseases have no treatment…  There are more than 6,000 known rare diseases... Approximately 80% of them have...

Tackling the complexity of pediatric clinical trials

Pediatric
Despite the evolution in pediatric legislation and a renewed interest in developing therapeutics for pediatric and rare diseases, pediatric clinical...

Kayentis & RWS partnering for success

Project management
Kayentis (global provider of eCOA and DCT solutions) and RWS (language service provider (LSP) and linguistic validation experts) were selected...

Mitigating the risks of long-term oncology eCOA clinical trials

Oncology
Long study duration can have a negative impact on patient complianceAs for any clinical trial, poor compliance in oncology studies...

Customizing eCOA questionnaire design to improve the pediatric experience

Pediatric
Dedicated to improve patient experience in clinical trials, Kayentis’ Clin’form solution offers the flexibility to customize questionnaire design with illustrations...

Addressing the specific complexities of oncology eCOA clinical trials

Oncology
The oncology research pathway is paved with numerous challenges, and oncology clinical trials have one of the lowest success rates....

Oncology Case Study

Oncology
Oncology studies present specific challenges that generate complex eCOA build and management: complex study design, frequent amendments, and long study...

Dermatology Case Study

Dermatology
Kayentis offers extensive expertise in dermatology and a solid experience with several typical PROs, ClinROs and Patient Diaries.With a large...

Digitalization Trends in Tackling the Complexity of Clinical Trials for Patients with Multiple Health Conditions

Rare disease
Patients participating in clinical research face a whole range of challenges, and it is particularly worse for those living with...

eCOA solutions in oncology: how to avoid common pitfalls and ensure the success of long-term studies?

Oncology
Among numerous clinical study procedures, capturing patients reported outcomes can bring its own set of challenges and, if not well...

eCOA challenges of long term studies

OncologyProject management
How to anticipate eCOA complexities in multi-year studies & develop best practice to support sites? Using eCOA solutions can bring...

eCOA in ophthalmology: The five keys for successful ePRO selection in your ophthalmology clinical trial

Ophthalmology
There is an extended use of Patient Reported Outcome (PRO) measures in clinical trials used to assess health-related quality of...

eCOA in ophthalmology

Ophthalmology
There is an extended use of Patient Reported Outcome (PRO) measures in clinical trials used to assess health-related quality of...

Infography: Overcoming complexities in pediatric clinical studies

Pediatric
Approximately one in every five pediatric clinical study fail1,2 . A 2016 study shows that over a three-year period (2008 -2011),...

Key #5 for successful ePRO selection in your ophthalmology clinical trial: Anticipate cultural differences in multi country clinical trials

Ophthalmology
https://youtu.be/-dWvQaRUwYs Before selecting a PRO for use in a large global trial, it is important to anticipate that responses to...

Kayentis supports the 1st personalized immunotherapy treatment approved by both FDA & EMA

Oncology
Acute Lymphoblastic or Lymphoid Leukemia (ALL) is a cancer of the lymphocytes that can result in serious complications such as...

3 reasons for using tablet for clinical data collection @Home

Electronic capture of patient data is increasingly replacing the use of paper-based diaries, and electronic Clinical Outcomes Assessment (eCOA) tools...

Overcoming the Complexities of Pediatric Clinical Trials

Pediatric
Although children make up 25% of the world’s population, at least 50% of all drug products may still lack labeling...

Key #4 for successful ePRO selection in your ophthalmology clinical trial: Consider the method of ePRO administration

Ophthalmology
https://youtu.be/cY5lYM_wBDQ PROs in ophthalmology trials can either be self-administered by the patient or the responses can be collected through an...

Key #3 for successful ePRO selection in your ophthalmology clinical trial: Get your patients involved

Ophthalmology
https://youtu.be/Cp7vd1fBKbc Although clinical research stakeholders strive to be patient-centered in their approach, dependence on clinical parameters alone is not enough....

Key #2 for successful ePRO selection in your ophthalmology clinical trial: Use your PROs to power economic evaluations

Ophthalmology
https://youtu.be/rH4yG-sxE9w Incorporating an economic evaluation within a trial provides valuable information for clinical decision making and coverage determinations, particularly when...

Key #1 for successful ePRO selection in your ophthalmology clinical trial: Ensure the ePRO answers the intended clinical endpoint

Ophthalmology
https://www.youtube.com/watch?v=eHQWWje4VwI&feature=youtu.be PROs have become a vital part of modern ophthalmology with an increasing focus on PROs within high-quality ophthalmic trials....

Actigraphy devices: a real impact on clinical research?

Actigraphy has been used in clinical trials for almost 20 years. Recently their inclusion in study protocols has been increasing,...

eCOA solutions in oncology: What to consider when planning an oncology study with eCOA /ePRO?

The FDA has provided guidance on methodology to be used for developing and using PRO in oncology drug development programmes,...

Key benefits of using a “Tablet device” for eCOA in Psoriasis studies

Psoriasis is a chronic immune-mediated inflammatory disease of the skin with various presentations and clinical courses. The commonly used measures...
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About the author
Picture of Marc Chaperon

Marc Chaperon

Estelle brings 20+ years of experience in pre-clinical and clinical research from Top 5 Pharma and Biotech firms. Leading projects across Phases 1 to 4 in diverse therapeutic areas, she offers deep insights into clinical science, operations, and regulatory intricacies. Appointed as Chief Medical Officer at Kayentis in May 2019.
Kayentis publishes its first ESG report, strengthening its commitment to responsible and sustainable clinical research
Discover our ESG report, which covers the fiscal year 2025-2026!
  • Read the report