Clinical Operations

Sitero delivers full-service clinical trial operations from study startup through closeout, supported by the Mentor eClinical platform. Our teams combine deep therapeutic expertise with proprietary technology to give sponsors a single accountable partner for both operational delivery and trial data.

We enhance the success of trials by leveraging our therapeutic, technical, and functional expertise to work collaboratively with our sponsors to ensure we provide an efficient, high quality solution. We have both global and local regulatory knowledge, strong relationships with investigational sites, and deep industry expertise that allows us to increase the effectiveness and efficiency of running a clinical program.

Clinical Operations Services

  • Study Feasibility Assessment
  • Study Design

  • Protocol development, review, and optimization

  • Investigator Identification & Selection
  • Subject Recruitment and Retention Strategies
  • Enrollment Projections & Management
  • Site Contract & Budget Negotiations
  • Investigator Payment Administration
  • Vendor Selection & Management

  • Clinical Monitoring Plan Development

  • Informed Consent Form Development
  • Trial Master File Creation & Maintenance/Regulatory Document Management
  • Regulatory and Site/IRB Submission Management
  • Investigator Meeting Coordination
  • Risk Management
  • Comprehensive & Risk-based Monitoring compliant with ICH E6 R2
  • CRA Management and Quality Control

  • Clinical Event Adjudication

  • Data and Safety Monitoring Board

Other Clinical Services

Biostatistics - Clinical Services Sitero

Biostatistics

Sitero offers a full suite of biostatistics and programming services to support your clinical research needs across a variety of therapeutic areas and specialties.

Medical Writing - Clinical Services Sitero

Medical Writing

Sitero provides high quality medical writing services for Biotech, Pharmaceutical, Consumer Health, and Medical devices companies across the Globe. Our team of well qualified and experienced Medical Writers have deep experience in writing Regulatory, Clinical, Scientific, and MedCom areas.

Data Management - Clinical Services Sitero

Data Management

Our global team of clinical data managers, statisticians, and statistical programmers provides solutions that cover the process of collecting, validating, and preparing the data towards statistical analysis for clinical trials.