About Actaphase
Actaphase is a local Contract Research Organization (CRO) based in Yerevan, Armenia. Established in 2022, Actaphase stands as a premium partner, dedicated to supporting Phase I-IV clinical studies, medical device research, and post-marketing activities.
Committed to the success of your clinical trials, Actaphase’s team of professionals provides specially tailored solutions to meet the needs of your clinical trial.
Actaphase is proud to have in-depth knowledge of the local regulatory environment in Armenia, successfully established partnerships with key medical institutions, and strong relationships with renowned medical professionals.
Mission and Vision
We aim to leverage Armenia's vast potential in drug development on a global scale. Having passed a qualification audit by one of the world’s top CROs, our goal is to deliver new therapies to patients, thereby improving and saving lives.
What We Focus On
Patient-Centricity
We value and respect the crucial role patients play in advancing medical knowledge. Our goal is to make their experience in clinical research positive and seamless.
Fast and High-Quality Data Delivery
We are devoted to delivering top-notch clinical data quickly. To achieve this, we focus on:
- Engaging Patients: Finding individuals who are committed to participating in clinical trials.
- Motivating Investigators: Collaborating with investigators who are dedicated to advancing medical research.
- Compliance with Standards: Ensuring our practices align with both local and international regulations.
Competitive Pricing
Offering cost-effective solutions without compromising quality.
At Actaphase, we aim to exceed expectations and leave a lasting impact on the future of healthcare.
Actaphase's Capabilities
As a delivery-focused premium partner, our capabilities span through all phases of clinical studies across a broad range of therapeutic areas, including medical devices. Services we offer, but are not limited to, are listed below:
- Project feasibility
- Study Site/Investigator Selection Preparation of submission packages, including translation of study documents
- Submission to and communication with the Local Regulatory Authority and EC
- Clinical study supplies management, import/export of shipments, including IMP
- Local Investigators meetings organization
- Contract negotiation, including investigators and institutions' payment management
- Monitoring for all phases of clinical trials, including sites’ training, patient recruitment and retention support, Close-Out
- Quality Assurance and Quality Control, including study oversight and CRAs performance management
- Provision of non-IMP medication
- Return and destruction of goods
Leadership
Nelly Yaneva, MD
Business Development Manager of Actaphase LLC
25 years of industry experience
- Clinical Team Leader at IQVIA Quintiles GesmbH —
Sofia, Bulgaria - Head Clinical Operations at PSI Pharma Support Intl. — Sofia, Bulgaria
- Director Clinical Operations and Administrative Head at Fortrea (Covance/LabCorp) — Sofia, Bulgaria
Dr. Nelly Yaneva established the Bulgarian offices of PSI Pharma Support (2002) and Covance (2006) and served as Country Head. Her passion for enterprise and proven track record of success are valuable and indispensable assets to any clinical research organization.
Hristiyan Kosturski, MD
CEO of Actaphase LLC
18 years of industry experience in clinical operations and drug development
- Clinical Trial Leader at IQVIA (Quintiles) Bulgaria
- Clinical Trial Physician/Scientist at Gruenental GmbH – Aachen, Germany
- Study Medical Expert at Bayer GmbH – Berlin, Germany
- CEO of a leading Clinical Research SMO, managing multiple studies at 12 European Oncology and University Research Centers
Dr. Hristiyan Kosturski is resourceful, experienced and, together with his team is able to offer unmatched services, ensuring a smooth and efficient course of all clinical research processes. He is a member of the Management Board of Directors of the Bulgarian Association of Clinical Research.
Quality and Reliability
Actaphase has a comprehensive Quality Assurance (QA) System, which guarantees excellence at every step:
- Internally developed SOPs: Standardized processes for precision.
- GCP trainings and staff: Continuous professional development.
- Corporate and project-related trainings: Adaptability to project needs.
- Risk management: Proactive measures for potential challenges.
- Internal audits: Transparent and accountable operations.
- Personnel oversight: Qualified and accountable team members.
- Vendors qualification: Careful selection of reliable partners.
- Task-specific trainings: Specialization and competence in specific roles.
Why Choose Us
Precision: Our team handles all important steps smoothly, i.e. figuring out if the trial is possible, choosing the right site, dealing with rules, approvals, contracts, and setting up logistics.
Experience Counts: Our experienced team can make sure that your study begins quickly and effortlessly.
Top-notch Quality: We carefully pick the best sites, balance patient access and staff involvement on site, and stick to the rules of the study.
Choosing us means having a team that understands the unique regulatory landscape in Armenia, ensuring a smooth and timely approval process for your clinical trial.