Clinical Data Management

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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 experts and avoiding the time-consuming delays 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 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 commit themselves to our clients’ long term success, operating with unparalleled flexibility and team spirit in partnership with our clients’ teams.

The essential role of Data Management within a Clinical Trial

 

With data being produced in such large volumes, at speed and often over a considerable period of time during a clinical trial, it is essential that a sponsor capitalizes on effective data management to orchestrate the processing of study data. The objective of any clinical data management team is to safely handle and collect this data, then to ultimately help the study’s stakeholders interpret and tell the story of the outcome of the trial in an accurate and insightful way.

A data management team can also enable an organisation to make its data more valuable. Since stakeholders rely so heavily on the data collected during a clinical trial in order to develop, create dosages for and gain regulatory approval different medications, being able to extract and analyse it confidently and at speed allows sponsors to take informed action with agility.

Since patients’ private information is being collected, high levels of clinical data management competence is required in order for a study to remain safe and compliant with regulatory expectations. Regulators demand that quality-assurance standards are met during every stage of a clinical trial, and that all data is safely stored and analysed, with password-protected databases, encryptions and other safety measures.

Every person in the study team should run regular quality and safety assurance checks, including:

  • Ensuring that all data accurately and consistently documented
  • Ensuring that collected data is audit- and submission-ready
  • Checking and correcting any anomalies and discrepancies of data

At Excelya we prioritise the integrity, quality and security of data. We have many policies and processes set in place in order to avoid human errors, ensure that privacy and security is realized, and so that data deliverables are delivered on time and on budget, and are of exceptionally high quality.

Industry Leaders in Data Management

The Excelya Difference

Excelya full service

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 monitor 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.

Excelya constantly upgrades 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).

Case studies

A 4-year partnership with a Top 20 Pharma 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.
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.

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.

Full-service data management

Our full-service offer takes into account all aspects from protocol design to final report. This includes eCRF design, database management, database review and validation as well as SDTM mapping and data study statistical analysis.

Our teams are made up of superior Clinical Data Management, Database Designers and CDISC Data Stewards, Biostatistics, SAS / SDTM Programmers and Medical Writers. A dedicated manager supervises each team and acts as both hierarchical and functional manager, ensuring deliverables quality and respect for project schedules.

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.

Why Excelya?

DEDICATED GLOBAL DATA MANAGEMENT TEAM

70 knowledgeable Data Managers across India/Europe

13 YEARS OF EXPERIENCE ON AVERAGE

A high level of task-related expertise, with up to 30 years of experience

EXCEPTIONALLY QUALIFIED TEAM MEMBERS

Our Data Managers have a Master/PhD level education and hands-on experience

HIGHLY KNOWLEDGEABLE STAFF

Experience in clinical studies across therapeutic areas and phases

Clinical Data Management, implemented with care

excelya FSP

Functional Service Data Management

  • Operational Excellence Centre: Qualified people, ready to go
  • Dedicated team to insert into your quality workflow
  • Governance using agreed KPIs and targets to drive performance management

Expertly-delivered Full Service Data Management

Protect and optimize the outcomes of your clinical trials with Excelya’s expertise and industry-leading clinical data management technology. Improve performance, reduce timelines and effectively manage costs by getting your data right, the first time.

With our Full Service data management solutions you can lean on the knowledge and thorough, highly developed processes of the Excelya data management team for the full delivery of your end-to-end clinical trial data journey.

  • Data management team executes all activities during the study life cycle, from database setup to database lock
  • Minimum 2 experienced Data Managers assigned per project to assure quality
  • CDISC standards to support cost-effective submissions
  • Two Excelya database options to fit your needs
  • Experienced operational management with and expert team of Project Data Managers, Clinical Data Managers, Technical Data Managers, Clinical Coders, Clinical Programmers and Associate Data Managers.