Industry Capabilities

Dedicated Site Solutions understands the challenges faced by the small/start-up pharmaceutical and biotechnology companies. Our team members have over 25 years of experience in the industry with successful track records of working on multiple approved products. We take on select projects and work within our means allowing us to offer personalized attention to your project needs and a quick start-up time.

What we offer for your projects:

Medical Monitoring: Our medical monitors come from diverse therapeutic backgrounds and have the clinical and research expertise required to provide medical oversight of your clinical trials.

·         Pre-IND meetings, IND support and FDA meeting attendance

·         Collaboration on agency responses and submission support

·         Providing input into the study protocol, informed consent forms, project risk assessment

·         Training investigational sites and study teams

·         Reviewing SAEs, coding of SAEs and writing safety narratives

·         Reviewing patient data to identify trends and risks across the study

·         Supporting investigational sites with queries around eligibility, safety etc.

Clinical Study Monitoring: Clinical trials are successful with efficient management and monitoring of clinical data. Dedicated Site Solutions’ monitoring team has an exceptional track record that ensures scientific excellence and data integrity across all sites. We engage a diverse group of specialized and people to perform all aspects of site management and monitoring.

We regionalize travel to limit costs to our client as efficiently as possible and have monitoring resources across the US states to accomplish this. On average our monitors have approximately 20 years of experience in monitoring. These stellar resources have experience in multiple oncology indications, including liquid and solid tumors and glioblastoma, chronic diseases, rare diseases, and device/diagnostics. Our monitors resources are well known and respected amongst many sites and with Key Opinion Leaders (KOLs) throughout multiple indications. These strong and respected relationships with a site can be one of the most invaluable assets to a clinical study for any sponsor, ensuring adherence to data quality, subject safety and issue resolution throughout a clinical program.

Comprehensive monitoring plans are developed to address complexity and sponsor requirements, and often combine traditional monitoring visits with robust site management and remote monitoring activities.

Clinical Trial Monitoring activities include:

·         Monitor visits – qualification, initiation, routine, and close-out

·         Comprehensive monitor plans

·         Expertise for feasibility or regulatory submissions

·         100% review of site records

·         Timely completion of visit reports

·         Quality review of monitor reports

·         Source document verification as per monitor plans

·         Rapid query resolution

·         Site training and support

·         Site management support and documentation

·         Periodic remote EDC review

·         Drug accountability

·         Co-monitoring

·         Rescue/SWAT monitoring

Project Management: Upfront planning results in fewer study delays and errors, assuring you receive high-quality study outcomes. Our clinical trial management philosophy supports all aspects of your early clinical trials cost effectively with clear roles and responsibilities.

Project Management support:

·         Develop the project plan and timeline

·         Qualification, selection, and oversight of vendors

·         Start-up activities and study initiation

·         Oversee study conduct and clinical monitoring

·         Manage data support teams from protocol development to clinical study report

·         Maintain and report metric deliverables

·         Provide for efficient project close

Some of our clients....  

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