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.
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.
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:
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.
A 4-year partnership with a Top 20 Pharma medical review team providing technical assistance followed by deliverables.
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.
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.
The challenge was to reconcile this essential refit on schedule while minimising the effect of sites’ own initiatives, finally achieved within the initial timeline.
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.
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
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.
