Flexible CRO

We believe that timelines and critical milestones are met through focus, priority and relevant experience. As a result, Accelovance is selective in the opportunities we pursue and dedicates a team 100% to each Sponsor’s study. We are also committed to team consistency – 97% staff retention.

Innovative study approaches incorporate the knowledge of CRO team members who average 18 years of industry experience, diverse therapeutic experience, clinical and medical expertise, and strong patient perspective.

Accelovance’s approach to study management is based on a patient-centric perspective, focused on what the study really needs: patients/subjects. We start first with an evaluation of the patient population and recruitment needs.  This is followed by an assessment of site resources and operations, and how the CRO will manage against challenges to ensure critical time, budget and quality needs are met. Team members are fully dedicated to a Sponsor to ensure focus and proper resource allocation.

Our Clinical Monitors (CRAs) include of a blend of in-house and full-time contractors regionally positioned across North America. Regional/Local CRA assignment minimizes or eliminates travel costs and maximizes the productivity and quality of each monitoring visit. Accelovance CRAs have a minimum of five years’ experience prior to joining our organization and are knowledgeable of all aspects of the study. They are highly skilled, therapeutically aligned, centrally trained and committed to excellence in every study. Quality CRAs ensure the integrity of the study, adherence to protocol, quality of measurements, safety of Subjects and valid data.

Accelovance offers both electronic data capture (EDC) and paper-based data management options, giving Sponsors options based on cost, timelines, study size and clinical strategy. We can implement our own data management system, Study Manager™, utilize a Sponsor’s proprietary system, or collaborate with a preferred third party vendor. Regardless of what system is used, Accelovance is flexible and focused on the quality and integrity of the data collected.  

Study Manager™ is both an EDC system and a clinical trial management system (CTMS). This dual functionality provides significant efficiencies and cost-savings; tangible value that is aligned with our corporate commitment to Sponsors.. Our core competencies in data management come from our knowledge of standards, our compliant systems and the effective use of our own commercially available data management system.

Accelovance statisticians have more than 25 years of industry experience across multiple therapeutic areas including oncology, vaccines, men’s and women’s health, infectious disease, consumer products and generics to name a few Depending on a Sponsor’s needs, Accelovance can provide statistical support or work with a Sponsor’s preferred statistician.

Services we can provide include: Aspects of Study Design, Analysis Planning, Data Analyses, Interim and Final Reporting and General Consulting.

Patient safety and quality data are critical to every study. Specializing in data capture, analysis, trend detection, and reporting, we work with our clients to conduct studies, analyze information, and prepare the appropriate reports. Our medical professionals work closely with Sponsors and other vendors, providing support and expert advice during each phase of drug safety development and analysis.

Accelovance’s Regulatory Strategy & IND Support team provides expertise and resources to help early-stage clients bring products into clinical development. We support biologics, drugs and medical devices with a comprehensive understanding of both regulatory and clinical affairs - blended knowledge that provides sound guidance for our clients. These individuals have more than 20 years of experience coordinating pre-IND packages, INDs, IDEs, 510Ks and BLAs/NDAs/PMAs; regulatory submission strategies; regulatory meeting preparation and attendance; and clinical trial launch. We have successfully supported US, EU and Asia Sponsors in their US regulatory filings.

Accelovance’s Regulatory Strategy & IND Support team provides expertise and resources to help early stage clients bring products into clinical development. We support biologics, drugs and medical devices with a comprehensive understanding of both regulatory and clinical affairs; blended knowledge that provides sound guidance for our clients. These individuals have over 20 years of experience coordinating pre-IND packages, INDs, IDEs, 510Ks, BLAs/NDAs/PMAs, etc. regulatory submission strategies, regulatory meeting preparation and attendance, and clinical trial launch. We have successfully supported US, EU and Asia Sponsors in their US regulatory filings.

Accelovance produces high-quality documents with the influence of scientific advisors, biostatisticians and technical writers who offer diverse therapeutic expertise. Clinical documents we prepare include: INDs, Protocols, Phase I-IV Clinical Study Reports (CSRs), Common Technical Document Modules, NDAs and Supplemental Documents, Safety Updates, Narratives, Abstracts and Manuscripts.