|

> Clinical Trials and Vigilance center

The Clinical trials and vigilance center has business and validation skills related to Vigilance systems (Pharmacovigilance, Cosmetovigilance Matériovigilance…), and, to Clinical trials: Electronic Data Capture (EDC), Electronic Case Report Form (eCRF), etc.

Our regulatory and technical expertise guarantees a high added value in terms of Data migration, System design, Validation, Audit, Codification...

 

  • Pharmacovigilance, ToxicoVigilance, MaterioVigilance, CosmetoVigilance, BioVigilance, HemoVigilance, InfectioVigilance, ReactioVigilance => see the NEWS
  • Management of Clinical Trials and patients data

 

These skills depend on requirements engineering. This activity includes technical activities:

  • Expression of needs in requirements
  • Analysis and balancing of requirements (justification and feasibility)
  • Conception then allocation of the requirements in sub/systems and guarantee of the traceability
  • Validation of the requirements 

 

And management activities:

  • Planning of deliverables
  • Conducting technical reviews of projects
  • Progress of the works
  • Control some evolution of the requirements in the time
  • Preservation of an up to date repository

 

This method brings:      

  • better adequacy of the product to the need of the customer
  • better communication between the stakeholders
  • better control of the costs / over the project 

The use of computerised systems for clinical recordings, patient data or vigilance is today a reality which exposes the clinical and pharmacovigilance departments, and health establishments (Hospitals...) to new challenges.

The clinical trials organization, pharmacovigilance and medical data becomes more global, with reporting mechanisms, transmission to the various departments and a dematerialization of all the processes: approval, management …

The reduction of the collection periods, the consultation and the provision of the information is an important stake which naturally supports  this tendency.

The Web and mobile technologies represent as such a real control lever of performance because they allow among others the availability of real-time data and a better traceability of actions. 

 



Beyond the reliability of the electronic systems, we ask the question of the quality of the data! This one is associated with the problems of archiving, data migration during the change of system and\or the numerous interfaces with the central systems of Data Management!

ADN assists in Audit, Training, Project ownership assistance and validation on all the implied systems, through professional consultants using our know-how in remote project management: Project and Project Server ( Web) associated with requirements engineering methodology.
ADN is also specialized in the validation of clinical data migration or pharmacovigilance on important volumetrics.

System references :

  • Pharmacovigilance (Argus, Clintrace, ARISg, Oracle AERS, ES/1 - Safety Manager, AgXchange ...)
  • Data Management (Clintrial, Oracle Clinical, Capture System, Webtrial, Inform, SAS, …)

 

 

Estimate the diagnosis, the treatment or the forecast of a disease. What are the risks?

  • The quality of a study is linked at once to the quality of the meditative medical data but also to the respect for the methods and the rules imposed by agencies AFSSAPS, EMEA, FDA.
  • The reassurance and the confidentiality of the data are the central points of the implementation of a clinical trial.
  • The modern tools and in particular the Internet present numerous advantages, both in term of reduction of cost of study and of contribution of quickness and quality, they go into a logic of efficiency of the clinical research.
  • To assure the quality and the admissibility by agencies, they have to be displayed and used in specific regulatory contexts : 21 CFR Part 11, GCP, ICH, Volume 9 and Volume 10.

 

The electronic identification of personnel is in the heart of the matter: centralized databases, ubiqutuous presence of the computer network raises the problem of the risk of data alteration, the risk of intrusion and leak of information, originating inside or outside the system.

The data exchanges and the streams of information between the various participants have to be the object of security procedures, require data encryption, the use of codes and passwords for every participant (CNIL, 21 CFR part 11), and the use of physical and electronic security systems.

Furthermore, the still use of relatively recent technologies in the clinical area requires at once specific training for the participants, a systematic risk management and validation of tools and methods.
  • The French health authority (AFSSAPS), the EMEA, the FDA and the ICH have released several guidelines and laws : the French Good Clinical Practice (Updated on Nov/2006)  - in the European and International areas :  ICH E6, ICH E2B , Volume 9 ....  – FDA texts as the famous 21 CFR part 11 but also 21 CFR Part 314, Part 312,  Part 50,  Part 56 ....&nbsp. Each actor of the pharmaceutical industry should comply with this regulation.
  • The transition of the regulatory requirements from “paper” to an electronic approach transformed the processes. New technologies are now part of the process and a harmonization is set up gradually following the recommendations of the FDA (Food and Drug Administration) concerning the recording and the electronic signature and of the CDISC, defining the standards for the acquisition, the exchange and the submission.

 

ADN has developed its expertise in E2B electronic submission through many interventions:

  • Beyond the validation of E2B gateway, we handle registration procedures in the different Health Autorities.
  • Also, many of our collaborators have the Eudravigilance - Electronic Reporting of ICSRs in the EEA, User Training Course Certificate.
  • ADN is also involved in the set up of Cosmetovigilance and Materiovigilance systems.

Currently, pharmaceutical companies shared data bases are growing up. These data bases extract and treat the data coming from several applications based on ETL – for Extraction-Transfer-Loading.

  • ADN handles the qualification of this type of tool, which manages generally regulatory and business critical data.
  • Records quality is important in the clinical research field and in the pharmacovigilance field (during clinical and post AMM phases). ADN is regularly qualifying migration of data in the PV and EDC (Electronic Data Capture) computerized systems.

 

Most solutions providers focus on the collection of data and on standard regulatory reports ( PSUR, CIOMS, SUSAR etc. ), giving the users the possibility to set their own indicators and avoiding  , a specific developement logic that could be antagonistic to a product line.

 

It should be noted that the projects focus, mostly, on the data entry processes and on the set up of electronic approval, giving less attention to regulatory reports.

 

The use of  Business Intelligence (BI) via the set up of indicators and of specific reports using Business Object or SAS Business Intelligence gives an assistance in the decision and allows to have a global view of the activity handled.

 

ADN works in developping its experience in BI to handel this issue.

 

ADN developed a pragmatic approach on the certification of SAS programs, based on well-recognized programming standards, a strong management of the changes, of configuration and versions.

This certification approach is an answer to the common validation process not adapted to the SAS programming activity, which is exposed to many changes.

An effort is made in the program conception, guaranteeing a high-value-added solution in the certification activity.

 

The computerization of Health Institutions has taken on a new lease of life.

  • The set up of Prescription Management Systems in the health institutions allows improving the quality of the prescriptions, to help health care professionals in their every-day work, to comply with the regulation associated to the prescriptions and to reduce, for an equal quality, the treatment cost.
  • On the 13 of August 2004 a new law was implemented to set up the DMP (the English equivalent is the Personnal Electronic Medical Record). It allows the improvement of the quality of the treatments received by the patient, a better traceability of the patient medical history and a better coordination between the several health care professional gathering around the patient.
  • The HAS (or French National Authority for Health) was set up by the French government in August 2004 in order to improve the quality of patient care and to guarantee equity within the healthcare system. The HAS, set up a certification related to the prescription management systems, which is mandatory starting January 2010. This certification allows a better quality of the treatments given by the health institutions and gives the patients information on the quality of the institutions concerned.

ADN is specialised in the validation of computerised systems, we shall bring our regulatory and technical expertise to bring our assistance to the health institutions to face these new challenges.