Our combined expertise and responsiveness ensure your research success!

The clinical trials team at Spectrum Research provides boutique-style services in all phases of clinical trial development and operations. The team at Spectrum can assist you in planning your clinical trials, as well as manage all the operational, technical and regulatory aspects of your projects. Our qualified team will interact directly with you to facilitate the effective and timely completion for meeting your clinical trial needs. In addition, if you need further assistance beyond clinical trial operations to include regulatory affairs, we have experienced staff to fill that need as well. The combination of our expertise and responsiveness ensures our clients receive the highest quality services to make their clinical trials successful. The team at Spectrum has the expertise to assist you through all aspects of your research and development process. The team consists of regulatory specialists, clinical researchers, epidemiologists, statisticians, database developers/managers, and clinicians with the ability to provide clinical services in the following areas:

• Therapeutic and diagnostic areas – Spectrum’s team has provided clinical trial management and operations services in orthopedics, including spine and trauma research; physical medicine and rehabilitation; diagnostic testing; dental implantology; anesthesia and pain management, both in adults and pediatrics; and drug delivery systems.
• Medical devices/combination products – Spectrum is experienced with clinical trial design, implementation, and analysis to facilitate formulation of 510(K) premarket notification, Investigational Device Exemption (IDE), Premarket Approval (PMA), Investigational New Drug (IND), and New Drug Application (NDA) submissions.
• Evidence-based reports – A comprehensive literature search, critique of evidence quality, and summary of pertinent research done by our team sets the proper stage for planning clinical research and supports FDA submissions.
• Outcomes research – The team at Spectrum can help you develop, implement, and evaluate outcomes related to your research and marketed products.

Spectrum’s clinical trials team will tailor our services to best suit the needs and budget of your business and regulatory strategies.

Clinical trial planning services include:

• Study design
• Sample size calculations
• Protocol development and review
• Evidence summaries of literature  
• Safety & efficacy endpoint selection
• Regulatory submission guidance

Our seasoned team can also assist you with a full range of research management products and services which can be combined to meet all your operations needs.

Management of clinical trial operations includes:

• Case Report Form (CRF) development (paper and electronic versions)
• Database development and evaluation
• Development of Standard Operating Procedures (SOPs) for investigators, Contract Research Organizations (CROs), and sponsors  
• Clinical trial monitoring and auditing
• Investigative site evaluation and selection
• Clinical Research Associate (CRA)/study coordinator training
• Project management of multi-site trials
• Institutional Review Board (IRB) and regulatory submissions
• Clinical Trial Agreements

Once your trial is completed or your product is ready for market, Spectrum is well prepared to assist with all of your post-trial surveillance and evaluation needs. 

Post-trial surveillance & analysis services include

• Post-market surveillance
• Post market evidence databases
• Evidence based summaries
• Statistical analysis and report writing
• Food and Drug Administration (FDA) submissions  
• Safety and efficacy assessments

Spectrum Research provides you with all you need to succeed!  Let us know how we can help you.

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