Experience, reliability, responsiveness in clinical and epidemiological research
Our project managers carry out studies in compliance with objectives, contractual commitments and schedules. They are the primary contact for the projects assigned. They have access to a multidisciplinary team adapted to the needs of the project, a backup, methodological and medical support of the operational and scientific management, quality assurance monitoring and the expertise of external consultants. Each project manager is assisted operationally by a project assistant.
The clinical operations department has centralised or regional CRAs available in all the countries covered. We are involved from site feasibility/selection. We perform set up (on site or by phone), remote monitoring (via EDC + RBM indicators), on-site monitoring and site closures on site or remotely. Our CRAs are independent and have the necessary hardware to remain connected continually to the various information systems of the company and the sponsor.
An ongoing activity since the origin of the company, this department has an expansive team capitalising on all the required research skills. We offer standardised, validated and documented processes. We offer digital solutions meeting international regulatory requirements for any type of study (21 CFR part 11, Gamp5), referenced dictionaries (Who Drug, MedDRA or the sponsor’s own), data formats conforming to current requirements notably in CDISC (SDTM, SAS, XML). Our reference tool (Ennov Clinical) – with which we have had recognised expertise for more than 10 years – has a complete functional coverage from monitoring to data management. The implementation of this software is validated in our IT system. It allows us to adapt to the constraints of the studies entrusted to us by online data entry (electronic CRF) or paper entry.
Our department brings together complementary skill sets with several senior biostatisticians and methodologists. Our specialists participate in designing protocols and writing analysis plans and reports (according to FDA, EMA, ICH-E9, ENCEPP, ADELF and HAS guidelines). They program analyses with SAS®, including the most recent methods such as the ADaM format, in study databases or external databases.
CONSULTING AND MEDICAL WRITING
CONSULTING AND MEDICAL WRITING
We can help our customers with the necessary strategy and study design for their goals, in a context of increasing requirements and changing regulations. We work with our internal and external consults on methodological, regulatory, technical and feasibility aspects. This can consist of occasional consultations or regular support. Our writers and our network of independent medical writers produce protocols, reports, articles and communications. We offer broad expertise in various therapeutic fields.
The fundamentals of the company rely on innovation in medicine, IT and research. We were the first to offer eCRF, IWRS and CTMS online solutions and mobile applications even closer to patients (ePRO, companion software, scoring). We regularly use customised tools in our studies designed to optimise data quality and the participation of physicians and patients.
The evaluation and monitoring of risks related to the use of a drug pre- or post-marketing is a priority. Our pharmacovigilance and materiovigilance services are adapted to the procedures and requirements of our customers and prospects. For this, we manage, at a minimum, the detection and notification of adverse events (AEs and SAEs). We also offer, depending on customer needs: entry and reporting of adverse events in reference databases, writing narratives according to customer guidelines, reconciliation management, request for additional information (RAI) management according to the local or global pharmacovigilance service, reporting cases to authorities, organising adjudication committees and writing any type of reports according to the study assigned.
Some services can be done by dedicated staff working directly on your site. Many staff profiles have been assigned in the past few years. We can also meet the needs of investigator sites with clinical research technicians (CRT) or clinical research nurses (CRN).
FIELDS OF EXPERTISE
OUR FIELDS OF EXPERTISE
We are able to support you in your studies whatever the field of expertise or the type of health product. We have a great deal of experience in clinical or epidemiological studies, medical devices, ATU/RTU/compassionate use programmes and in other types of health products.
Study of the various factors that are involved in the onset of diseases, their frequency, their mode of transmission, their progression and the implementation of the necessary means for preventing them.