Consulting & operational expertise · End-to-end clinical trials
OKILYS Life Science
12 years of experience in clinical research, from the field to project coordination, at the service of your clinical trials.
Let's discuss your study →- Study design
- Start-Up
- Conduct & close-out
- Project coordination
- Clinical Oversight
Insights
All insights →About us
Qualified expertise, tailored to each study
OKILYS Life Science is a dynamic French company built on senior expertise in Clinical Research. We work across every category of trial: drugs, medical devices, standard-of-care evaluation, research on collected data and Non-Pharmacological Interventions (NPIs).
OKILYS assesses your needs and then provides the expertise best suited to your current or upcoming studies: study design and site selection, Start-Up, contracts and regulatory activities (SSU & Contract Specialist, SSU Lead), coordination within sites (Study Coordinator), investigator site monitoring (Senior CRA), study management (Clinical Trial Lead), quality supervision of vendors (Clinical Oversight Manager),… Every assignment can be followed from design through to close-out.
OKILYS ensures rigorous follow-up of every assignment, from scoping to close-out. Building on the trust of its partners and a commitment to global health, the company continuously broadens its services across all these categories of research.
Our values
HOME: what guides every one of our assignments
Human
People's health is the starting point and the end point of every study. We keep the patient and the site teams at the heart of decisions — because a successful trial is, first of all, people who are well supported.
Objectivity
Hospital, CRO, sponsor: having held every position in the chain gives us an unbiased view of a study. We see everyone's constraints, we bring them into dialogue, and we say what we see.
Mastery
Knowing the procedures, good clinical practice and European and national regulations is not about enduring constraints: it is about knowing where a study can get stuck, and anticipating it. The rigour that secures timelines, data and patients.
Engagement
Being engaged means holding the course as much as delivering the result: the first negotiated contract and the last patient followed receive the same attention, and every step is carried out with the same standard through to close-out.
OKILYS Life Science puts its expertise at the service of future generations' health
Clinical development
From health product to patient
Drug, medical device, real-world data, standard of care or non-pharmacological intervention: each category follows its own development journey. OKILYS works on the clinical research side of each of these journeys.
Drug
Phases I to IV: first-in-human and dose escalation, dose finding, pivotal confirmation, then real-world follow-up — including advanced therapy medicinal products (ATMPs) and GMO products.
Explore the journey →Medical device
Clinical investigation: safety and clinical performance in humans, from prototype to post-market clinical follow-up (PMCF).
Explore the journey →Data
RWD/RWE studies, retrospective or prospective, on care data, registries and health data warehouses.
Explore the journey →Standard of care
Research with minimal risks and constraints, or non-interventional: care follows usual practice, the research lies in the data collection.
Explore the journey →Non-Pharmacological Interventions
Adapted physical activity, nutrition, psychotherapy, digital health: clinical evaluation facing intervention standardisation and the absence of blinding.
Explore the journey →Five journeys, one field of action: the clinical study,
from design to close-out.
End-to-end
Our expertise, from design to close-out
Each bar shows the study stages covered by an OKILYS field of intervention.
1. Design
Strategic advice based on trial type (including non-standard or early-phase trials), protocol & synopsis, ICF: writing, country adaptation, French translation review (FR, BE, CH), eCRF, CTMS, patient-facing tools2. Site selection
Country and investigator site selection: feasibility, selection visits3. Preparation
Collection of site essential documents, contract & budget negotiation (Convention Unique, Pharma.be), ARS & CNOM notifications, submission package preparation4. Submissions
Submission strategy based on trial type · EU Regulation: CTIS Part II · National frameworks: ANSM & CPP, CNIL/HDH (FR), FAMHP & Ethics Committees (BE) — initial & amendments, up to Greenlight (approval + signed contract)5. Site initiation
Initiation visits, team training, site activation, first patient in6. Conduct & monitoring
Patient recruitment, monitoring & recruitment-boosting visits — on-site or remote (RBM, DCT), close communication & escalation, data quality, eTMF, risk & deviation management7. Close-out
Site close-out visits, final query resolution, drug & material returns, TMF/eTMF reconciliation & archiving, study wrap-upFor any other need, we would be glad to discuss how we could work together.
Contact usOKILYS suite
A suite of tools to run your clinical trials from A to Z
Tools born from cross-cutting field expertise, for field teams — adopt the whole suite or single modules, for your study or for your clients.
OKILYS CTMS
Clinical trial management: site lifecycle, visits and signed reports, follow-up actions, submissions and contracts, reporting — modules on demand, data handed back at any time.
Discover OKILYS CTMS →OKILYS eTMF
The Trial Master File structured per the TMF Reference Model, fed automatically by the CTMS (documents, submissions, contracts, signed reports) and verified by your teams.
Discover OKILYS eTMF →Sectors, areas & trial types
Sectors and areas of intervention
We support all clinical research stakeholders — industry, CROs, institutional sponsors and investigator sites — on drug trials, medical device studies, real-world data studies (RWD/RWE) and Non-Pharmacological Interventions (NPIs), across many therapeutic areas.
Sectors
Therapeutic areas
Oncology
Cardiology
Endocrinology
Respiratory
Gastroenterology
Neurology
DermatologySpecific populations
Pediatrics
Pregnant womenContact
Contact OKILYS
Are you recruiting for a clinical research position? Lydie PARSUS is considering opportunities matching the roles and expertise presented on this site. Write to us and we will get back to you shortly.
Contact details
Let's talk about your study
-
Company
OKILYS Life Science — SIREN 881 686 497
Frequently asked questions
Do you handle clinical trials from A to Z (full service)?
We work on targeted assignments, at one or several steps of the study — from design to close-out — depending on your needs. If your study requires skills beyond ours, we can point you towards one of our partners.
What types of products do you work on?
On the clinical research side of drugs, medical devices, real-world data studies and standard-of-care evaluations. Each of these journeys is detailed in the Clinical development section. Non-Pharmacological Interventions (NPIs) are a field we want to move into — we say so plainly on the dedicated page.
Do you only work in France?
No: our skills allow us to work, depending on the steps you need, across several countries and regions — in Europe and beyond.
What is Clinical Oversight?
It is the sponsor-side supervision of a study's vendors (CROs, service providers), required by good clinical practice. OKILYS sets it up and runs it on your behalf.
How quickly can you start an assignment?
We discuss your needs in detail and propose a timeline suited to the scope and urgency of your study.