Accelsiors
Accelsiors is a global, full-service Contract Research Organization (CRO). Since 2002, they have been committed to providing Sponsors working in highly complex disease indications with the scientific knowledge, regulatory expertise and quality operations necessary to achieve their development objectives.
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| Accelsiors | |
|---|---|
| Type | Private |
| Industry | Biotechnology |
| Founded | 2002 |
| Slogan | Plan, Accelerate, Control, Execute |
| Headquarters | 103. Haros str.
1222 Budapest Hungary |
| Number of employees | 201-500 |
History
In June 2002, Mihály Juhász, MD, CEO, established Accelsiors Limited Partnership Company in Budapest, Hungary. Initial activities were related to regulatory consultancy services and as Customers requested, services were broadened to include clinical monitoring services with complementary SOPs.
In 2003, the company expanded to include project management and established the Quality Assurance department. The reputation for delivery was recognized and were soon involved in multi-center global studies offering full service.
As the team expanded, teams in logistics, training, pharmacovigilance and medical monitoring were added. The company relocated to new facilities in Budapest, where they remain until today.
In 2007, Accelsiors established their Biometrics department to include data managers, statisticians and medical writers.
IT and HR were expanded to manage the demands of a growing organization. Today the company have 17 office locations and operational capabilities in over 30 countries.
In 2015, they introduced their PACE initiative to further strengthen and harmonize study management processes and procedures. They implemented a weekly recruitment booster initiative to complement the monthly Project Review Meetings and completed the hiring of their Senior Management Team.
In 2016, Accelsiors celebrated their 14th year in business. Their teams are continuing to expand and deliver quality data to exceed the Customers' expectations.
Services
- Biostatistics
- Clinical Monitoring
- Data Management
- Medical Writing
- PK/PD Modeling
- Project Management
- Quality Assurance
- Regulatory
- Safety and Medical Management
- Feasibilty & Study Start-up
- Record Management
SAFETY AND MEDICAL MANAGEMENT SERVICES:
- Medical Management:
- Eligibility Verification-Confirmation process
- Medical consultations (e.g. eligibility criteria, protocol design, requirements and restrictions)
- Review and analysis of safety listings and tables
- Safety signal detection and analysis
- Medical coding.
- Pharmacovigilance:
- Periodic Safety Reporting (DSUR and periodic line listings)
- SAE/AE/ADR handling (collection, database entry and evaluation)
- Identification of AEs of special interest and appropriate handling
- Provision of CIOMS and/or MedWatch forms for all SAE reports within expected timelines
- Registration with EudraVigilance
- Overdose handling (collection, database entry and evaluation)
- Pregnancy handling (collection, database entry and evaluation)
- 24/7 safety surveillance - available to Investigators for all PV related questions
- Peri-marketing PV services.
- Data Safety Monitoring Board (DSMB) management:
- Member selection
- Charter development
- Meeting support and coordination.
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News
EHR FOR CLINICAL STUDIES SESSION CHAIRED BY ACCELSIORS’ SVP OF OPERATIONS AT ACDM ANNUAL CONFERENCE
Accelsiors is proud that the Electronic Health Records for Clinical Studies Section of the ACDM Annual Conference will be chaired by our Senior Vice President of Operations, Jon Wood.
The 31st ACDM Annual Conference will be held in Brussels on the 13th March 2018 for professionals working in the data management sector with the aim to discuss the latest changes, innovations and challenges in clinical data management.
The excellent keynote speakers will get you thinking about all aspects of data management in the wider medical world, as well as the familiar themes that will support your personal and professional development, and keep you up to date with ongoing changes in the industry.
The areas being covered are Electronic Health Records, current topics in data management such as Risk Based Monitoring, data visualisation, data transparency & privacy and digital healthcare. The Annual General Meeting will also take place
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