Full-service trial operations from Phase I–IV, site & patient management.

At Geistek, we deliver end-to-end clinical trial management that combines scientific rigor, regulatory compliance, and operational excellence.
Our integrated teams oversee every phase of your study — from protocol setup and site activation to data management and close-out — ensuring each milestone meets the highest standards of quality and GCP compliance.

Our Capabilities

We provide comprehensive clinical operations for pharmaceutical, biotech, and medical device programs across all phases of development.

Clinical Project Management

Full oversight of timelines, deliverables, and budgets.

Site Selection & Activation

Identification, qualification, and startup of high-performing sites.

Monitoring & Quality Oversight

Risk-based and on-site monitoring strategies to ensure data integrity and patient safety.

Patient Recruitment & Retention

Targeted enrollment planning and engagement support for sustained participation.

Vendor Management

Coordination and supervision of CROs, labs, and service providers.

Pharmacovigilance & Safety Reporting

SAE/AE tracking and submission in accordance with GCP and ICH guidelines.

Study Close-Out & Audit Readiness

Comprehensive documentation and inspection preparation for sponsors and authorities.

We ensure your clinical program runs smoothly, on time, and inspection-ready.

Our Approach

At Geistek, trial management goes beyond logistics, it’s about aligning science, operations, and compliance.

Integrated Operations

Clinical, regulatory, and data teams collaborate from study design through database lock.

Regulatory Precision

Every process adheres to international guidelines (ICH-GCP, EMA, FDA, ISO14155).

Risk-Based Monitoring

Adaptive strategies that focus resources where they matter most.

Technology-Driven

eClinical platforms (EDC, ePRO, eTMF) for real-time data and remote oversight.

Patient-Focused

Each study is designed to be safe, ethical, and patient-centered.

Continuous Quality

QA involvement throughout the study lifecycle to ensure inspection readiness.

Therapeutic Experience

Geistek’s clinical operations span multiple therapeutic areas with specialized expertise in:

Oncology

Precision Medicine

Cell & Gene Therapies

Immunology

Metabolic / Obesity

Medical Devices

Partner With Us

Whether you need full-service trial management or specific functional support, Geistek acts as an extension of your team, combining agility, precision, and compliance.