The Clinical Operations Department is composed of Project Managers, Clinical Trial Assistants and Clinical Research Associates who manage the projects entrusted to us. Our operational resources operate in autonomous mode, with the occasional support of Senior Directors, according to the needs and the nature of the projects. Guaranteeing the satisfaction of our customers is the number one objective of the teams who advocate collective intelligence, communication and the desire to progress in order to surpass themselves.
We intervene from the feasibility/selection of the centers. We carry out the initiation (on site or by telephone), remote monitoring (remote monitoring with EDCs and RBM indicators), on-site monitoring and closure of sites on site or remotely. Our Clinical Research Associates are autonomous and have the necessary computer equipment to remain permanently connected to the company’s various information systems and thus remain available to Sponsors/investigators.
A long-term activity since the company’s origins, this department has an extensive and expert team, capitalizing on all the business skills sought. We offer standardized, validated and documented processes. We offer digital solutions that meet international regulatory requirements for any type of study (21 CRF Part 11, GAMP 5, GDPR), referenced dictionaries (WhoDrug, MedDRA or specific to the Sponsor), data formats that comply with current requirements, in particular under CDISC (SDTM, SAS, XML). Our reference software (Ennov Clinical®) – with which we have recognized expertise of more than 15 years – has full functional coverage from Monitoring to Data Management, including ePRO for patients. The implementation of this software is validated in our environment. It allows us to adapt to the constraints of the studies entrusted by an online entry (electronic CRF) or a paper entry. We also offer an EDC suitable for early access program.
Our department brings together complementary expertise with several Senior Biostatisticians and methodologists. These are specialists who participate in the design of protocols, the writing of analysis plans and reports (according to FDA, EMA, ICH-E9, ENCEPP, ADELF, HAS guidelines). They program analyzes with the SAS® system, including the most recent methods such as the ADaM format, on the basis of studies or external databases.
The scientific and medical background of the leaders is one of the particularities of the company. We put our skills and experience at the service of our clients by providing them with advice and expertise in the strategy and design of studies. We work with our internal and external consultants on methodological, regulatory, technical and feasibility aspects. This can be one-off advice or regular support. Our writers and our network of independent medical writers produce the protocols, reports, articles and communications. We offer broad expertise in different therapeutic areas.
Technical assistance has become an essential strategy for companies wishing to optimize their resources and accelerate their projects. We provide you with qualified consultants, carefully selected to meet the precise requirements of each project. We are committed to providing you with highly skilled professionals who fit perfectly into your teams. They will bring their knowledge and experience to contribute to the success of your projects. We offer profiles such as project managers, data managers, CRAs, statisticians and many other professions.
The fundamentals of the company are based on innovation from medicine, IT and research. We were the first to offer online solutions eCRF, IWRS, CTMS, and mobile applications ever closer to patients (ePRO, software companions, scoring). We regularly use in our studies tailor-made tools intended to optimize the quality of the data and the participation of investigators and patients.
Assessing and monitoring the risks associated with the use of a product before or after it is marketed is a priority. To do this, we manage at least the detection and notification of adverse events (AEs and SAEs). We also offer, according to the client’s needs: the drafting of the Safety Management Plan (SMP), the management of reconciliations, the follow-up of requests for additional information from the Sponsor’s vigilance department, the organization of adjudication committees.
On site services
Some services can be performed by dedicated personnel working directly on site. Many staff profiles have been allocated in recent years. We can also respond to requests from investigation sites with Clinical Study Technicians or Clinical Research Nurses.
ACUITUDE, the holding company of the AXONAL-BIOSTATEM group, provides consulting, training and assistance services in the field of health. Our fees management platform facilitates the management of the remuneration of healthcare professionals by the pharmaceutical industry.
ACUITUDE develops complex tailor-made projects by bringing together specific and different expertise.
Projects over 30 years