{"doi":"10.1017/cts.2024.1168","title":"A maturity model for Clinical Trials Management Ecosystem","abstract":"Introduction: Managing clinical trials is a complex process requiring careful integration of human, technology, compliance, and operations for success. We collaborated with experts to develop a multi-axial Clinical Trials Management Ecosystem (CTME) maturity model (MM) to help institutions identify best practices for CTME capabilities. Methods: A working group of research informaticists was established. An online session on maturity models was hosted, followed by a review of the candidate domain axes and finalization of the axes. Next, maturity level attributes were defined for min/max levels (level 1 and level 5) for each axis of the CTME MM, followed by the intermediate levels. A REDCap survey comprising the model's statements was then created, and a subset of working group members tested the model by completing it at their respective institutions. The finalized survey was distributed to all working group members. Results: We developed a CTME MM comprising five maturity levels across 11 axes: study management, regulatory and audit management, financial management, investigational product management, subject identification and recruitment, subject management, data, reporting analytics & dashboard, system integration and interfaces, staff training & personnel management, and organizational maturity and culture. Informaticists at 22 Clinical and Translational Science Award hubs and one other organization self-assessed their institutional CTME maturity. Respondents reported relatively high maturity for study management and investigational product management. The reporting analytics & dashboard axis was the least mature. Conclusion: The CTME MM provides a framework to research organizations to evaluate their current clinical trials management maturity across 11 axes and identify areas for future growth.","journal":"Journal of Clinical and Translational Science","year":2025,"id":560727,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9489,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1463121,"name":"E. Chris Pua","orcid":null,"position":1,"is_corresponding":false},{"id":593545,"name":"Svetlana Rojevsky","orcid":"0000-0002-8353-9006","position":2,"is_corresponding":false},{"id":64725,"name":"Michael J. Becich","orcid":"0000-0001-5998-8074","position":3,"is_corresponding":false},{"id":1463122,"name":"Joshua Fehrmann","orcid":null,"position":4,"is_corresponding":false},{"id":621076,"name":"Boyd M. Knosp","orcid":"0000-0002-3834-3135","position":5,"is_corresponding":false},{"id":225275,"name":"Adam Wilcox","orcid":"0000-0002-6305-735X","position":6,"is_corresponding":false},{"id":513825,"name":"Jeffery Talbert","orcid":"0000-0002-4304-5167","position":7,"is_corresponding":false},{"id":973143,"name":"Catherine K. Craven","orcid":"0000-0001-9647-3045","position":8,"is_corresponding":false},{"id":488216,"name":"Justin Starren","orcid":"0000-0002-5403-1115","position":9,"is_corresponding":false},{"id":763001,"name":"Shruti Sehgal","orcid":"0000-0001-6352-8628","position":0,"is_corresponding":true}],"reference_count":26,"raw_metadata":null,"created_at":"2026-07-19T02:55:46.921885Z","pmid":"40052053","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}