Services
Functional Service Provider
Streamline your Clinical Trial with Accelsiors FSP Solutions
In today’s fast-paced clinical research landscape, biopharmaceutical companies are turning to Functional Service Providers (FSPs) to optimize their clinical trial operations. FSPs allow organizations to outsource specific functional aspects while retaining control over the study and data.
By partnering with Accelsiors, you can:
- Focus on core competencies by delegating time-consuming trial tasks
- Reduce costs by converting fixed expenses into variable costs
- Access a pool of highly skilled professionals across therapeutic areas
- Scale resources up or down seamlessly to meet evolving study needs
- Mitigate risks associated with resource constraints and quality issues
- Leverage our cutting-edge technologies and innovative proprietary solutions
Accelsiors offers tailored FSP services spanning clinical data management, biostatistics, pharmacovigilance, risk-based monitoring, medical writing, and clinical monitoring. Our dedicated team works closely with you to develop customized programs aligned with your systems and processes.
With over 22 years of experience and a proven track record, Accelsiors is your trusted partner for optimizing clinical trial operations through FSP solutions.
Clinical Monitoring
Our team of experienced medical monitors provides oversight and ensures patient safety throughout clinical trials. We offer flexible resourcing models to embed medical monitors within your teams, leveraging their therapeutic expertise. Our medical monitors review safety data, manage safety reporting, and collaborate closely with clinical teams.
With our medical monitoring services, you can maintain robust patient safety practices, ensure regulatory compliance, and uphold the highest data quality standards, driving successful study completion.
Site Management
Effective site management is crucial for successful clinical trials. As part of our flexible Functional Service Provider (FSP) model, Accelsiors offers comprehensive site management services. Our seasoned site management professionals can be seamlessly integrated into your teams to oversee site operations. We provide tailored solutions, from staffing individual site managers to building complete centralized or regionalized site management teams.
Our experts ensure optimal site selection, training, monitoring, and communication to drive enrollment, maintain data quality, and ensure adherence to study protocols. By leveraging our site management capabilities through the FSP model, you can optimize site performance, mitigate risks, and accelerate study timelines.
Clinical Data Management
Our data science experts will support you with insightful solutions in all aspects of handling and analysis of clinical study from database design and set-up through data collation to its reporting across all phases of your study. They help to focus on the clear translation of the protocol into CDISC-compliant data structures, efficient data validation and review tools. Accelsiors’ data management experts will support you to make well-informed decisions on the right time and assist you to protect patients and ensure reliable, quality study results.
Biostatistics
Our experienced clinical biostatisticians and clinical programmers facilitate the success of your clinical research program in a significantly regulated environment and help to make thoughtful decisions at every phase in clinical development. Our experts have in-depth statistical knowledge of experimental design, statistical methodology and global regulatory requirements to help design your trial for better decision making.
Clear endpoints, clear design, clear insights, and clear route to successful outcome – let us help with all of these.
Pharmacovigilance & Drug Safety
Accelsiors’ safety management team offers medical expertise and patient safety support to our sponsors across all geographic regions. Work with our team of skilled professionals who have extensive experience in medical management, pharmacovigilance and always up-to-date knowledge of constantly changing regulatory requirements for safety services.
Let our safety team support you in IMP safety profile definition and the management , detection and minimization of safety concerns and important safety risks in order to ensure patient safety.
Medical Advisory Board Management
Accelsiors provides professional solutions for the management of clinical study expert panels to ensure excellence in science, trial safety, data quality and impact. Our experts bring together appointed representatives from clinical research, academic partners and health systems across the countries to provide a forum to share information, and achieve higher certainty levels in safety and efficiency of Assessments. Additionally, the potential local judgement bias can overcome with the assistance of our highly customizable Experts Collaboration Panel eClinical technology solutions including:
• Endpoint Adjudication Panel (EAP),
• Data and Safety Monitoring Board (DSMB),
• Diagnosis Confirmation Panel (DCP).
Record & Documentation Management
Our TMF qualified staff is here to guarantee the successful conduction of your trial. Accelsiors’ experienced, devoted record management experts will help you to design and manage the TMF Process with emphasis on quality and compliance with a strong focus on the continuous inspection readiness.
Let us help you with a proactive and efficient management of critical study documentation. Your data is our priority and ultimate deliverable.
Medical Affairs
Accelsiors’ clinical research professionals and physicians with extensive medical monitoring, staff training and data review experience can help you in the planning, conduct, monitoring and evaluation of your clinical studies and strengthen your on-the-ground abilities with field-based medical teams.
Let us connect you to the know-how you need with personalized medical liaison programs. We provide a team of subject matter experts to support, tailor and manage your study, advise you on the optimal directions from the design and study assessment of your clinical trial to the delivery of meaningful & high-quality results.
