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Study Management

MakroCare’s experienced team provides comprehensive clinical trial management services. We enhance the success of trials and programs by working collaboratively with our sponsors, anticipating challenges, and managing trials proactively. Our superior global and local regulatory knowledge, strong relationships with investigational sites and medical experts, and highly experienced cross-functional teams enable us to deliver world-class clinical trials powered by cutting-edge technologies.

MakroCare’s global clinical trial managers oversee the timely initiation of clinical trials, including global feasibility assessments, site and vendor selection, risk management planning, subject recruitment and retention strategies, and enrollment projections. Throughout the conduct of trials, we provide real-time reporting metrics to manage enrollment progress and monitor site expectations, activity and performance.

Trials are monitored centrally as well as by clinical research associates (CRAs) at the clinical sites, based throughout the world and matched to the protocol requirements in indication and experience. Utilizing regional, seasoned professionals and, if requested, remote monitoring and targeted source document verification, MakroCare maximizes cost efficiency in the conduct of these trials.

MakroCare’s agility and technical innovation make our team a collaborative extension of our Sponsor partners. Our highest priority is to develop fit-for-purpose, project-specific clinical trial solutions that deliver high quality results and adhere to regulatory requirements.

Our Services

  • Bullet Global Study Feasibility Assessment
  • Bullet Investigator Identification & Selection
  • Bullet Subject Recruitment and Retention Strategies
  • Bullet Enrollment Projections & Management
  • Bullet Site Contract & Budget Negotiations
  • Bullet Investigator Payment Administration
  • Bullet Vendor Selection & Management
  • Bullet Clinical Monitoring Plan Development
  • Bullet Informed Consent Form Development
  • BulletTrial Master File Creation & Maintenance/Regulatory Document Management
  • BulletRegulatory and Site/ IRB Submission Management
  • Bullet Investigator Meeting Coordination
  • Bullet Risk Management
  • Bullet Comprehensive & Risk-based Monitoring compliant with ICH E6 R2
  • Bullet CRA Management and Quality Control

MakroCare’s Clinical Team - A Snapshot

  • BulletAverage of 10 years of experience
  • BulletExperienced in major therapeutic areas including oncology and rare diseases
  • Bullet In-house and regionally based in USA, UK, Europe, India, and Singapore


The First Step

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