Accell
Accell Clinical Research is a full-service clinical CRO dedicated to completing clinical trials on time with a focus on innovation, regional expertise, and operational excellence. They specialize in oncology and other therapeutic areas, providing services from study setup to management and rescue studies, with a strong presence in Eastern Europe, Russia, the USA, and expanding into Latvia and Ukraine. Their mission is to give hope to patients by ensuring timely and reliable clinical trial execution, leveraging regional offices and strategic alliances.
Industries
Nr. of Employees
small (1-50)
Accell
Products
Cloud-based eCRF platform
Electronic case report form system for clinical data capture with CDASH conformance and support for validation to 21 CFR Part 11.
Validated eTMF platform
Electronic Trial Master File solution validated for regulatory inspection readiness and 21 CFR Part 11 compliance.
Online oncology advisory forum
Online platform to organize advisory boards and provide consultancy with oncology subject-matter experts to support protocol design and strategic advice.
XLC
Brand for bicycle parts and accessories within the Accell Group portfolio.
Babboe
Cargo bike brand in the Accell Group portfolio specializing in family cargo bikes.
Carqon
Premium cargo bicycle brand in the Accell Group portfolio.
Cloud-based eCRF platform
Electronic case report form system for clinical data capture with CDASH conformance and support for validation to 21 CFR Part 11.
Validated eTMF platform
Electronic Trial Master File solution validated for regulatory inspection readiness and 21 CFR Part 11 compliance.
Online oncology advisory forum
Online platform to organize advisory boards and provide consultancy with oncology subject-matter experts to support protocol design and strategic advice.
XLC
Brand for bicycle parts and accessories within the Accell Group portfolio.
Babboe
Cargo bike brand in the Accell Group portfolio specializing in family cargo bikes.
Carqon
Premium cargo bicycle brand in the Accell Group portfolio.
Services
Operational management of multinational clinical trials including project management, monitoring, data management, medical monitoring, safety reporting, QA, and TMF management.
Provision of dedicated clinical operations professionals (CRAs, coordinators, project managers) to supplement sponsor teams under FTE-based contracts.
Assessment and implementation of rescue strategies for underperforming trials including adding sites/countries, oversight of existing CROs, and focused recruitment measures.
Study feasibility, country and site selection, regulatory strategy, documentation development, advisory board facilitation, investigator meetings, and budget/contract negotiation.
Local regulatory representation, preparation and filing of submissions, and pharmacovigilance reporting support for studies conducted in European Union and regional jurisdictions.
Implementation and wider use of CTMS functionality for project management and budget control, with staff training and rollout to improve study oversight.
Operational management of multinational clinical trials including project management, monitoring, data management, medical monitoring, safety reporting, QA, and TMF management.
Provision of dedicated clinical operations professionals (CRAs, coordinators, project managers) to supplement sponsor teams under FTE-based contracts.
Assessment and implementation of rescue strategies for underperforming trials including adding sites/countries, oversight of existing CROs, and focused recruitment measures.
Study feasibility, country and site selection, regulatory strategy, documentation development, advisory board facilitation, investigator meetings, and budget/contract negotiation.
Local regulatory representation, preparation and filing of submissions, and pharmacovigilance reporting support for studies conducted in European Union and regional jurisdictions.
Implementation and wider use of CTMS functionality for project management and budget control, with staff training and rollout to improve study oversight.
Expertise Areas
- Clinical trial management
- Patient recruitment and retention
- Oncology clinical research
- Vaccine clinical trials
Key Technologies
- Cloud-based eCRF platforms
- CDASH-conformant data standards
- 21 CFR Part 11 compliant systems
- Validated eTMF platforms
News & Updates
Meet Accell’s team at the biggest pharma industry event of 2022 – CPHI Frankfurt, held at Messe Frankfurt, Frankfurt, Germany on November 1-3, 2022.
Learn numerous advantages of running an oncology clinical trial in Eastern Europe from Accell’s team, held in June 2022.
Natalia Nayanova attended the conference in New York City in February 2020.
Meet Accell’s team at the biggest pharma industry event of 2022 – CPHI Frankfurt, held at Messe Frankfurt, Frankfurt, Germany on November 1-3, 2022.
Learn numerous advantages of running an oncology clinical trial in Eastern Europe from Accell’s team, held in June 2022.
Natalia Nayanova attended the conference in New York City in February 2020.