Global Data Operations

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Delivering proficiency and on-time plans

Clinical and pharmaceutical industries are becoming increasingly data-oriented.
Collecting, processing, integrating data and the ability to transform data buckets into triggers for success are becoming critical challenges in regulatory affairs. But that is not all.
The mix between these industries and IT proficiency highlight two major challenges. These involve finding the right kind of specialized expert and avoiding the time-consuming traps IT can involve related to team recruitment and management.

Our exclusive organization

Swift, secure and collaborative management

We focus on identifying and recruiting the most suitable experts for clients’ projects, based on our powerful HR team and methods which enable us to offer them relevant profiles, sometimes within a few hours.
Whether our mission is organized on a platform or otherwise, our operational teams work closely with our team managers, allowing us to keep on schedule without any delay in the projects we lead. Our exclusive organization based on our teams’ human value is also the best way of guaranteeing our missions’ superlative quality. Our enthusiastic, reliable and creative teams really do commit themselves to our clients’ long term success, operating with unparalleled flexibility and team spirit in partnership with our clients’ teams.

Clinical Data Management

Excelya’s data services stand out by making users the focus of all considerations, processes and proposals. For example, experienced teams monitoring their activities, managers and mentors backed by the ongoing training customers require. This also includes regular feedback geared to improve our processes in line with their needs and expectations.

Excelya’s Data teams and Managers collect and clean clinical study data as well as

monitoring exterior teams backed by Data Stewards to ensure data complies with current CDISC standards. We also create an additional DB for other resources using variables, forms, and dictionaries to record patient data during the study.

Data Programmers and Report Analysts also use SAS, R or Python to transform, analyze and create data to manage additional therapeutic fields.

Overseeing our team members involves more than recording their successes. Excelya is constantly investing proactively to insure they flourish professionally and personally via various events our teams organise. These involve team building cohesion in a pleasant and relaxed atmosphere to build a feeling of belonging to a real and vibrant community.

Excelya is constantly upgrading deliverables and links with team members and customers, backed by online recruiting, training and team monitoring further implemented by developing proprietary and innovative solutions. These statistical, analytical and predictive approaches mirror market, customer demand and team monitoring fluctuations. Statistical analysis and analytical/predictive models also keep us in pace with market fluctuations, customer demands and our team members.

After inheriting an ongoing study, our Data Management consultant realised the need for an eCRF and fresh study programming. “The challenge was to reconcile this essential refit on schedule while minimising the effect of sites’ own initiatives, finally achieved within the initial timeline.” (Jean-Charles Delarue, Data Management Consultant for Sanofi).

Clinical data standardization and integration

A 4-year partnership with the Servier medical review team providing technical assistance followed by deliverables.

The team consists of 10 PhD pharmacists/scientists focused on combining medical review and database management aimed at combining all ongoing clinical studies.

The client selected Excelya to oversee its medical data review of all phase I, II and III clinical studies in various fields (oncology, cardiology, rheumatology, etc.), from protocol review to database freeze.

This covers medical data coding (via MedDRA and WHODD dictionaries), a weekly

appraisal of issue severity, reviews of any deviations or medical data consistency noted in the electronic notebook (eCRF).

Excelya’s edge:

  • Swiftly integrates new team members and expands their skills.
  • Improves quality and/or responsive performance.
  • Ability to improve existing processes, quality and/or swift responsiveness
  • Positive environment (flexibility/mutual assistance) with minimal turnover since thelaunch.
  • Excelya’s ongoing flexibility in line with client needs (reorganization), plus activities (on the client’s premises, then at Excelya and now remote working), while maintaining initial quality and performance.

Key figures: Initially 3 CROs on the MRD platform (2016), fewer now. 11 Excelya team

members working in the departments (average experience: 2 years).

How does Excelya bring its futuristic innovations into the present?

  • By assimilating tools used by clients to develop and maintain genuine technical mastery designed to constantly improve them.
  • Initiating workshops allowing consultants to present subjects or processes they have mastered to the entire department.
  • Working with the customer to develop new tools, although distribution within the company is not planned for several years (from SAS software to R, involvement in creating new coding)
  • Some consultant pharmacist develop their thesis on the client’s premises (process redesign, e-health)

Biostatistics services and SAS programming

This programming department is devoted to one of the key activities required to carry out a clinical trial. Team members are involved throughout the entire process, from the start of the study implementing the protocol (design, number of subjects, stratification, etc.) until the final analysis is delivered. This will reflect the choices made in the protocol and the statistical analysis plan. (Excelya is able to provide its customers with everything from Full Service to customer support and technical expertise). the presentation of a well-constructed submission file, and to enable launch in the investigation centers according to the study schedule.

Regulatory affairs

These consist of Superior Clinical Data Management, Database Designers and CDISC Data Stewards, Biostatistics, SAS / SDTM programming and MedicalWriting.

Taking in all aspects from protocol design to the final clinical report. These include eCRF design, database management, database review and validation as well as SDTM mapping and data study statistical analysis.

These consist of a dedicated manager supervising each biometrics team. S/He acts as both hierarchical and functional manager, is responsible for deliverables quality and also ensures project schedules are respected.

This team meets customer needs by implementing personalized strategies and acts in line with 3 service delivery models. It is a dedicated team with unique expertise and even a full package service.

Our tools, software and quality process allow us to oversee all operational activities and maintain compliance with GCPs, while remaining flexible with regard to our customers’ constraints.

This team of 15 is set up on a customer’s premises with an operational invoicing system available within 6 months. This activity is monitored and then incorporated into the platform at Excelya.

Our Success Stories

Save time, gain expertise

Thanks to its extensive network of KOLs and partners on the major continents, Excelya was able to find an extremely rare expert profile for a major pharmaceutical laboratory in just a few days. The client had struggled to find the right level of expertise for many months, resulting in the project concerned falling significantly behind their schedule. Available immediately, the new recruit was able to make up some of the time lost.

We were very impressed by the effectiveness of the EXCELYA process because we were able meet the candidate the day after having received the profile.