Quality Assurance


Quality is integrated into the fiber of our day to day operations. SPRI management, functional teams, and staff are united in the pursuit of customer-focused continuous evaluation and improvement to consistently meet our high standards.

Working within a quality management framework our quality assurance principles are consistently applied to all activities and systems. Our procedures are described in a comprehensive set of standard operating procedures (SOPs) which have been written to comply with ICH/GCP guidelines, local regulations, the Code of Federal Regulations and the EU Clinical Trials Directive.

Feasibility and Site Selection

Our global feasibility and site selection services are designed to help our clients assess the local medical management and the challenges that may impact their study timelines. **At SPRI we employ industry leading technology including: pharmacy data, prescription records, heat maps, trial result databases and survey tools. Use of these cutting edge tools has increased our global reach and reduced turn around time.


Feasibility Assessment Process


GATHERING/ASSESSING

  • Careful review of the clinical trial design
  • Assessment of the competitive landscape
  • Discussion with key clinicians to assess potential issues that may affect recruitment and study execution
  • Identification of potential site interest
  • Internal Discussions with our Clinical Operations Teams

ASSESSING/SHARING

  • Protocol design areas that may affect protocol execution
  • Regulatory considerations
  • Logistical considerations
  • Country and region suggestions
  • Clinical trial site selection and projected enrollment rate by country

Regulatory Management

Leveraging our local expertise, SPRI’s regulatory team can proactively guide you through potential challenges to provide a faster initial submission and review process. Our clinical trial compliance experts will closely monitor the risks associated with each submission in order to optimize your research timelines and ensure the success of your study.

Once the clinical trial has begun, you can rely on this same team of professionals to take care of all ongoing interactions with the regulatory agency. Count on SPRI to handle all details of the clinical research compliance process, including:
  • Amendments
  • Serious Adverse Event (SAE) reporting
  • SUSARs
  • Annual reports
  • Study close-out reports

Project Management


It’s always a challenge to integrate the functional components of a clinical trial, and to provide tightly coordinated communication — but at SPRI, our experienced project managers are up to the task. We maintain a high level of interaction among all project teams, focusing on building strong relationships and adherence to study processes. Our goal is to streamline the communication process in order to avoid duplication and information overload, helping to deliver a more effective, more efficient research process.

A Proactive Approach to Clinical Operations Management

  • Motivating and training clinical sites to maximize patient enrollment and retention
  • Ensuring timely delivery of CRFs to ensure an efficient database lock
  • Facilitating communication flow at all levels
  • Regular tracking of study metrics
  • Early identification of emerging issues and potential solutions
  • Providing clear expectations to sites, clinical team, vendors and client

Clinical Monitoring


At SPRI, we understand the importance of bringing safe, effective therapies to the market. As a company, we provide our CRAs with the tools to do their job — but it is the CRA who adds their expertise, care, and attention to their job each and every day.

Our CRAs are trained in ICH/GCP guidelines, as well as local regulations, the Code of Federal Regulations and the EU Clinical Trial Directive. Additionally, SPRI’s ongoing internal training program ensures that our CRAs are up to date on the latest industry trends and practices.

Over 72% of our clinical team members have medical backgrounds, enabling them to partner with clinical sites on the most complex trials. We look for CRAs with proven interpersonal skills, who can mentor and work closely with clinical sites, as well as SPRI’s functional teams.

Risk-Based Clinical Monitoring
At SPRI Clinical Trials, we’re committed to quality, efficiency, and effectiveness throughout the research process. As part of this commitment, we continue to look for ways to reduce costs and ensure quality data for our clients. With the right clinical site and selection of data review, as well as our comprehensive risk management tools and highly trained CRAs, SPRI’s risk-based clinical monitoring services may be the best choice for your upcoming trial.

Biometrics

SPRI has chosen not to standardize on one Electronic Data Capture (EDC) platform, but to instead broaden our experience and knowledge base in order to meet the needs of our clients. While SPRI’s clinical data management teams are proficient in all the major EDC systems, we have chosen to partner with two EDC providers to integrate their processes into our workflow. Our collective goal is for you to have an end product that is CDISC, CDASH, and STDM compliant to ensure you are submission ready.

Data Management will ensure the foundation is in place for data integrity:
  • Annotated Case Report Forms
  • Electronic Case Report Form Guidelines
  • Transfer Data Specifications
  • Data Review (query generation, review & resolution)
  • Medical Coding (Adverse Events and ConMeds)
  • SAE Reconciliation with safety database
  • Imports and Exports from outside sources
SPRI partners with experienced statisticians to provide clinical biostatistics services:
  • Trial design
  • Sample size determination
  • Statistical analysis plan
  • Randomization management
  • Blinded review
  • SAS tables, figures and listings
  • DSMB support

Logistics


At SPRI, our logistics management team will be involved in trial discussions from the beginning, taking a proactive approach to ensure that your project runs smoothly from start to finish. We’ll make sure that the clinical team has what they need, when they need it — whether you’re purchasing equipment or drugs in-country, or need us to coordinate shipment from abroad. With SPRI on your side, you can trust your paperwork, drug shipments, and other clinical trial logistics to be handled with efficiency and professionalism.

Our Knowledgeable Team can be counted on to:
  • Ensure a clear chain of custody is maintained
  • Identify secure storage areas with limited access
  • Identify ambient, cold storage, and freezer storage availability
  • Identify Liquid nitrogen storage (available at many locations)
  • Ensure the facility chosen has temperature-monitored back-up power

Consultants


As clinical trials become more complex it’s important to partner with the right team, or individual, who has the experience to augment your team’s expertise.

Abstracts, Manuals & More

Our highly qualified medical, scientific, and technical writers have in-depth knowledge in their chosen specialties, allowing them to craft well-written, data-driven documents. Whether your needs include authoring, editing, or reviewing, turn to SPRI for medical writing services.

SPRI’s technical writing capabilities include:
  • Abstracts/Posters
  • Informed consents
  • Protocols and amendments
  • Study procedural manuals (including pharmacy manuals)

Medical Management:
  • DSMB Support
  • Medical Monitor
  • SAE Narratives