Services

At CLINÉCA, we provide a full spectrum of services designed to streamline and enhance every stage of your clinical trial.

From initial feasibility assessments and swift project start-up to comprehensive contract management and patient recruitment, we ensure each process is handled with efficiency and precision.

Our expert project managers oversee every phase to maintain timelines, while our quality management system guarantees compliance with GCP and study protocols.

Partnering with us means having access to an extensive network of patients, experienced investigators, and a proven track record in delivering successful, high-quality clinical research results.

Feasibility Management

We manage feasibility requests centrally, working closely with experienced investigators to ensure the best outcomes. Each request is carefully assessed to provide a tailored, realistic evaluation.

Our team provides a detailed list of potential study sites from our extensive network, ensuring that all project needs are fully met.

Project Start-Up

CLINÉCA maintains a robust database for start-up documentation.

Our local site research coordinators handle the rapid preparation and submission of essential documents, ensuring a fast, efficient, and smooth process for all submissions.

Contract Management

Our centrally managed contract services ensure maximum standardization, led by a single point of contact.

We streamline the contracting process by providing comprehensive support to sponsors, CROs, and investigators, simplifying and speeding up negotiations for all parties involved.

Recruiting Support & Concept Development

Our extensive network of referring physicians and research centers covers a substantial part of Bulgaria, providing access to a vast pool of patients. This enables us to rapidly meet recruitment targets, even for rare conditions.

Our sites are based in the largest university hospitals in Bulgaria, offering access to a wide and diverse patient population. Patients with chronic conditions are well known to our physicians, with their details securely stored in our internal database, ensuring seamless follow-up and participation in long-term studies. This close doctor-patient relationship leads to higher inclusion rates and lower dropout rates.

We apply innovative recruitment strategies, including online marketing, digital recruitment campaigns, and direct cooperation with physicians. Our experience allows us to customize these approaches to meet the specific needs of each clinical trial, ensuring the best recruitment outcomes for even the most challenging studies.

Project Management

CLINÉCA’s project managers anticipate and manage risks to ensure the delivery of successful results on time, covering every aspect of the clinical trial process – from site feasibility, communication, and supply handling to study follow-up and final database lock.

Our project managers serve as the primary point of contact, handling all communications with sponsors and CROs, ensuring smooth, high-quality recruitment studies.

Additionally, project management supports both clinical research sites and CRAs. This direct communication is key to identifying potential risks early, enabling us to develop strategies to swiftly address any issues. Our team follows a proactive, solution-oriented approach, ensuring optimal project outcomes.

Quality Management

To ensure the highest quality in all our clinical trials, we manage and monitor operational processes through our sophisticated CTMS system. We implement detailed SOPs for each process, focusing on data integrity and subject safety.

Our internal audits ensure compliance with protocols and GCP, supporting continuous process improvement.

Our Training

CLINÉCA offers a comprehensive training system designed to enhance the professional skills and competence of our staff. We provide a range of training sessions, from basic Good Clinical Practice (GCP) training to advanced project-specific instruction.

Our team also supports investigators and other stakeholders in overcoming recruitment challenges, ensuring the delivery of exceptional results and adherence to study requirements.

Privacy

With the implementation of the General Data Protection Regulation (GDPR) on May 25, 2018, privacy and data protection have become critical aspects of our work.

CLINÉCA actively supports its sites in developing and implementing standardized data protection protocols to safeguard patient information. We are committed to ensuring compliance with privacy regulations across all network sites, offering guidance and templates to ensure secure patient interactions.

Daily Activities at the Sites

Under the guidance of the investigators, CLINÉCA’s highly skilled site research coordinators handle a variety of non-medical tasks, constituting 70-80% of the total clinical trial workload. These activities include:

  • Contact with Independent Ethics Committees (IEC) and assistance with document submissions.
  • Protocol and GCP compliance.
  • Reporting and tracking safety information.
  • Quality control oversight.
  • Logistics management, including subject visits, CRO and sponsor visits, drug accountability, and lab sample handling.
  • Management of study files, eCRF data input, and query resolution.
  • Data cleaning, inventory management, and project file archiving.