Excelya combines a people first culture with flexible delivery models so sponsors get consistent execution and senior level attention where it matters most.
Excelya operates with audacity, care, and energy, focusing on ownership, proactive problem solving, and long term partnership.
Excelya supports global delivery with 1000+ experts, 16 offices, and presence across 25+ countries.
Excelya has supported 550+ clinical trials across Phase I to IV and a broad range of therapeutic areas.
Excelya uses a structured Quality Management System with ISO 27001:2023 coverage and a strong track record including 200+ client audits and 20+ authority inspections.
Excelya maintains measurable commitments such as a 2025 Gender Equality Index of 97 out of 100 and an EcoVadis 2024 Silver rating of 92 out of 100.
Excelya supports clinical operations across Phase I to Phase IV, including study management, monitoring, study start up, regulatory submission coordination, and site and vendor oversight.
Excelya improves operational efficiency through experienced delivery teams, standardized governance, and proactive risk management that reduces rework and delays.
Excelya embeds quality through documented processes, ICH GCP alignment, continuous oversight, and clear decision trails that support inspection readiness.
Yes. Excelya supports global and multi country delivery across 25+ countries with centralized oversight and local operational expertise.
Sponsors can choose Full Service, FSP, or Resourcing models to match study needs, timelines, and budget.
Excelya uses milestone driven planning, KPI tracking, and early risk escalation to protect timelines and reduce cost surprises.
Excelya manages clinical trial data from collection through validation to database lock, ensuring reliable datasets for analysis and reporting.
Excelya’s CDM team includes 100+ experts with an average of 9+ years of experience.
Services include eCRF design, database build, edit checks, query management, data review, and closeout activities supporting database lock.
Excelya works with leading platforms such as Veeva Vault, Viedoc, and Oracle Clinical One based on sponsor requirements.
Yes. Excelya can support rapid setup with a go live target around 12 weeks, depending on scope and readiness.
Excelya offers Resourcing, FSP, and Full Service models for scalable CDM delivery.
Excelya provides statistical and programming support across the clinical lifecycle, delivering analysis outputs and reporting that are regulatory ready.
Services include design support, sample size, randomization guidance, interim and final analysis, and SAP development.
Excelya programmers build validated datasets and generate TLFs, supporting CSR outputs and submission quality deliverables.
Excelya supports standards such as CDISC SDTM and ADaM and commonly uses validated tools such as SAS.
Excelya applies structured QC, peer review, and documentation practices to ensure accuracy and traceability.
Excelya supports flexible delivery via Resourcing, FSP, or Full Service, depending on your scope and timelines.
Excelya provides pharmacovigilance support across the product lifecycle, adapted to sponsor needs and regulatory requirements.
Excelya brings 20+ years of experience and has supported 300+ vigilance projects.
Excelya supports safety operations focused on detecting, assessing, understanding, and preventing adverse effects, including key reporting and oversight activities.
Yes. Excelya supports safety needs in 50+ countries through global coordination and local expertise where required.
Excelya uses in house safety databases, SOPs, and lean project management, reporting no critical findings in PV audits or inspections and 50%+ zero finding results.
Excelya offers Resourcing, FSP, and Full Service models for scalable PV delivery.
Excelya supports medical writing from clinical documents to publication support, balancing scientific accuracy with clear communication.
Excelya has 100+ medical affairs professionals working across 25+ countries with an average experience of about 10 years.
Excelya supports protocols, CSRs, lay summaries, regulatory documents, abstracts, posters, manuscripts, and other lifecycle documents.
Excelya has contributed to 100+ peer reviewed papers, supporting sponsors with publication strategy and high quality writing.
Yes. Excelya adapts writing for regulators, clinicians, patients, and scientific audiences with consistent terminology and compliant structure.
Excelya offers flexible models including Resourcing, FSP, and Full Service depending on workload and deadlines.
Excelya supports eTMF operations to keep trial documentation complete, traceable, and inspection ready throughout the study.
Excelya supports eTMF delivery using platforms such as Veeva Vault based on sponsor requirements.
Excelya improves TMF oversight and readiness through controlled processes, structured filing governance, and quality checks.
Excelya offers full service eTMF, standalone support, migration support such as pTMF to eTMF, and readiness reviews.
Excelya provides trained eTMF specialists supported by governance and quality routines to maintain ongoing readiness.
Excelya helps reduce delays by improving documentation visibility, completeness, and timely reconciliation across milestones.
Excelya provides a clear path to regulatory approval by ensuring confident, accurate, and timely document submissions.
Excelya’s regulatory team has up to 20 years of experience across therapeutic areas, phases, and industries.
Excelya supports development and submission strategy, EU planning, CA and EC submissions, responses to authority questions, public registry activities including FVLP, and amendments through completion.
Excelya supports applications such as DCP, MRP, and national procedures, as well as post authorisation maintenance, variations, renewals, and transfers, including publishing in eCTD.
Yes. Excelya supports high quality translations for SmPC, labeling, and patient leaflets, plus regulatory intelligence, local consultancy, and registrations for medical devices, food supplements, cosmetics, and biocides.
Excelya leverages flexibility, multidisciplinary experience, strong relationships with health authorities, and deep regulatory knowledge to support timely conclusion of procedures.
Excelya helps maintain compliance amid increasing regulatory scrutiny across GxP regulated activities.
Excelya provides simplified reporting, easier audit preparation, improved document management, and increased process visibility.
Excelya supports SOP writing and updates, gap analysis, risk assessment and management, GxP training, internal and vendor audits, vendor evaluation, CAPA follow up, and monitoring local and EU legislation.
Excelya can act as local QA and QP, adapt global SOPs, assess subcontractors, audit distribution centers, manage PQCs, manage deviations, perform root cause analysis, build CAPA plans, and support recalls and self inspections.
Excelya supports GCP training for investigators and site staff recognized by TransCelerate, site coordinator training, site audits and pre inspections, lab evaluation, and setup of units for Phase I and BE/BA studies.
Yes. Excelya supports ISO 27001:2023 certification and GDP certification for medical devices.
