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Clinical Study Management

Study management is critical to the success of every project. Our experienced professionals deliver superior service by taking a collaborative approach to study management. This approach, combined with exceptional organizational and interpersonal skills, creates a responsive, client-driven environment.

Services include:

  • Site selection and feasibility assessments
  • Study start-up and pro-active study planning
  • Risk management
  • Collaborative interaction with regulatory authorities and ethics committees
  • Site contract and budget preparation, negotiation, and administration
  • Organization of investigator meetings and site training
  • Electronic trial master file management
  • Recruitment and retention support
  • Drug safety/pharmacovigilance
  • Data safety monitoring board support
  • Coordination of site/vendor/client communications
  • Study budget management and forecasting
  • Tracking project performance metrics to ensure deadlines are met

Clinical Monitoring

Our clinical research associates are known for their outstanding client service, attention to detail and in-depth knowledge of industry regulations and guidelines. They verify compliance with protocols, quality standards, data collection and regulatory guidelines–ensuring the highest quality data for your clinical trial.

Services include:

  • Site selection, initiation, interim monitoring, and close-out
  • Remote monitoring
  • Site personnel training, mentoring, and guidance
  • Assessing protocol compliance and data integrity
  • Regulatory document review
  • Pharmacy training and drug accountability
  • Ensuring adherence to GCP, regulatory, confidentiality, and safety requirements
  • Support audit/inspection readiness

Data Management

We offer a full spectrum of data management services and expertise to optimize your data. Our clinical data managers rigorously follow standard operating procedures that encompass security, industry regulations and ICH/GCP. They work collaboratively and cross-functionally to ensure all stakeholders needs are met. We use a comprehensive, but easy-to-use, cloud-based clinical data management platform that supports a wide range of study types and designs.

Services include:

  • Data management planning
  • CRF and database design
  • Quick EDC database build and validation
  • EDC functionality, including:
    • ePRO
    • Medical coding using MedDRA and WHODrug
    • Lab normals
    • Targeted SDV
    • Reporting dashboard with real-time access to datasets on demand
  • Role-based security and access control
  • End-user training, including CRF completion guidelines
  • Third-party data import
  • Ongoing data cleaning and query management
  • Clinical trial safety database/reconciliation
  • Database lock activities and archiving

Biostatistics

Biostatistical design and analysis are central elements of any clinical trial. Establishing a sound biostatistical plan results in optimal study design and high-quality data output. Comprehensive statistical input during the early stages of a clinical development program decreases overall costs and accelerates timelines to regulatory approval.

Services include:

  • Sample size calculation
  • Randomization list
  • Protocol development support
  • Providing input into CRF design and annotations
  • Statistical analysis plan
  • SAS programming and validation of tables, listings and figures
  • Interim and final data analysis
  • Supporting medical writers with abstracts, manuscripts, posters and final clinical study reports
  • Database lock and archiving procedures
  • Data safety


Decentralized Clinical Trial Solutions

Our decentralized clinical trial services are patient-centric and designed to improve the patient’s experience, which leads to better patient engagement and increased retention rates. We make it easy for patients to participate, by bringing trial activities to them wherever they are located: home, work or in-clinic. This allows us to reach a larger, more diverse pool of patients for your clinical trial.

Our success is rooted in our people.

Meet our experts

Jeff Smith

Jeff Smith is the President of two healthcare companies, Allphase Clinical Research Inc. (est. 2001) and Alio Health Services Inc. (est. 2012). Allphase implements and manages Phase 2 to 4 clinical trials for pharmaceutical products and medical devices. Alio Health specializes in Patient Support Program services that include assisting patients in securing reimbursement for expensive specialty medications and providing administration services, facilitated by a specialized proprietary software for maximal efficiency. Collectively both companies employ more than 370 permanent staff and over 500 nurse contractors across Canada. In January 2020, Allphase and Alio were acquired by Calian Group Ltd. Jeff remains at the helm of both organizations.

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Kaytlin Sadler

As Vice President, Kaytlin contributes every day to the mission at Alio Health, acquired by Calian in 2020. She helps define and execute Alio’s strategic objectives and plans for new business opportunities. Overseeing internal operations and building strong client relationships, she has helped maximize Alio’s operational pace to achieve real outcomes. Kaytlin played a key role in the strategic evolution of Alio’s Health Outcomes Management Engine™ (HOME) innovative software that meets industry needs and is helping to shape where the industry is headed. In keeping with Alio’s efforts to challenge and empower its employees, she has built a strong, confident team of diverse yet like-minded individuals.

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Patricia Moore

Patricia is the Vice President, Operations of Allphase Clinical Research Inc. and has been with the company since 2004. Responsible for operational management and business leadership, she is dedicated to the successful and efficient execution of our customer’s clinical trials.

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