Methodological and Statistical Consulting

You are a company that develops health products (drugs, medical devices) or an institutional Sponsor, RCTs will allow you to benefit from a tailor-made partnership with specialists in clinical research, pharmacoepidemiology, health-economics or the management of secondary data.

Our experts are available to support you in the positioning of your research, your objectives, the choice of your data source, the statistical hypotheses, the appropriate study design, the inclusion and non-inclusion criteria, the calculation and the rationale for the sample size and the feasibility of the study.

Frédéric Mistretta President
Flavien Roux Head Biostatistics - Expert in regulatory-oriented clinical studies
Audrey Lajoinie Head of Secondary Use Data Studies - PharmD and methodologist, expert in the evaluation on secondary data, in particular medical and administrative data from the French Claim Data Base (SNDS)
Project Management

RCTs’ consultants will guide you in the regulatory strategy to be used with the authorities (ANSM, HAS, CPP, CNIL, CNOM, INDS, CEREES, …) whatever the type of study:

Interventional clinical trial
Real-world assessment on primary or secondary data
In France or in an international setting,
For a drug or medical device …

Our teams are specialized in full-service management of clinical trials or real-world evaluations and are involved in all stages of the project: recruitment of investigators, contract management, treatment management, site initiation, monitoring, coordination, reporting, etc.

Morgane Champiot Study Director - Former co-pilot of the "Regulatory - CNIL / MR" working group of AFCROs
Audrey Lajoinie Head of Secondary Use Data Studies - Member of the Real World Data working group and specialized in the evaluations on secondary data, in particular medico-administrative data
Monitoring

RCTs coordinates the monitoring of studies in France and abroad (via PSNResearch).
At the start of the project, depending on the context and the risk analysis, the monitoring volume is defined in order to determine:

The strategy of site initiation

The frequency of monitoring visits according to a fixed or risk-based monitoring approach

Telemonitoring

Site close-out

 

In order to ensure this monitoring, RCTs has experienced CRAs located all over the country, management tools adapted to monitoring allowing availability in real-time of:

Data to be monitored on site or via remote monitoring

Quality indicators defined at the start of the study according to the context

Detailed reports allowing periodic data reviews in order to adapt – if needed – the strategy and the pressure of monitors on the investigational sites

Data Management

RCTs relies on a solution that meets international regulatory requirements (21 CRF part 11, Gamp5, EU GMP Annex 11, ISO14155: 2012, HADS, ISO27001) for any type of study. This agile solution is made up of modules (eCRF, pCRF, ePRO, IWRS, eTMF, Coding, eConsent, CDMS) that can be activated as needed. A team of developers can implement, if needed, functionalities adapted to the specificities of each study.

Our team of data managers in constant interaction with our clinical operations is at your disposal to best define the data entry and data control strategy.

RCTs is a member of the CDISC community and has strong expertise in the design of CRFs in CDASH format, database lock in SDTM format and analyses in ADaM format.

Statistics

RCTs’ statisticians will guide you from the drafting of the protocol to that of the statistical report, as well as in the drafting of your scientific publications. The team, composed of biostatisticians, SAS programmers and data scientists, complies with the guidelines in force (FDA, EMA, ICH, HAS, ENCEPP, ADELF …) and the type of study:

Interventional

Non-interventional

Big Data exploitation from secondary data (French Claim Data base / Health Data Hub medico-administrative databases)

 

Depending on the context, RCTs offers the most appropriate analysis methods from the following:

Frequentist statistics

Bayesian statistics

Artificial Intelligence / Machine Learning using supervised or unsupervised learning methods

 

RCTs has developed know-how in data visualizing and highlighting results in graphical form, regardless of the statistical tool used (SAS, R, PYTHON, etc.).

Flavien Roux Head of Interventional Studies Biostatistics - Expert in regulatory-oriented clinical studies
Frédéric Mistretta President
Medical writing

RCTs has a team of experienced medical writers to assist you in the design and promotion of the results of your research: protocol, study report, national or international publication, poster or abstract.

Morgane Champiot Study Director
Audrey Lajoinie Head of Secondary Use Data Studies
Regulatory Strategy / Clinical Evaluation of Medical Devices

Our experts specialized in medical devices will help you define and justify the class and status of your device as well as establish a regulatory development plan that will thoroughly specify all the activities to be carried to obtain the CE-marking.

They will also support you in creating and updating your Clinical Evaluation Plans and Reports (CEP and CER) or help you with a specific part of the clinical evaluation (e.g., definition of keywords, bibliographic research, medical device vigilance research, etc.).