Clinical Trials

BIO1 is Biomapas’ early phase unit located in Lithuania’s leading university hospital-Vilnius University Hospital, Santaros Clinics (≈1400 beds). 

Reasons for customers selecting BIO1 include the following: 

• Excellent environment for patient recruitment due to investigators being financially and scientifically motivated, and where there is generally easy access to patients and healthy volunteers.
• Ethics committee time to approval is approximately 1-2 months.
• Strong partnerships and cooperation with key opinion leaders in a wide range of therapeutic areas who can bring their expertise to protocol development, clinical conduct and data analysis.
• The hospital’s ICU is in the same building.
• The BIO1 team has particular expertise in oncology, cardiology, dermatology and gastroenterology.
• The unit has 12 beds and is already appointed to expand to 20 beds if needed.
• The facility offers a large clinical space of 500 m² plus an administrative area of 120 m² – all of which is modern, immaculate and has the very latest equipment.

BIO1 offers a safe and comfortable environment for patients or healthy volunteers.  It provides each  customer with a project manager as a principle point of contact who oversees the whole process from recruitment to clinical study report.

The facility covers all types of early phase clinical studies, including first-in-human and proof-of-concept, single and multiple dose, bioequivalence, bioavailability, drug-drug and drug-food interaction, PK/PD, tQTc studies. 

Additional services include:

• Protocol writing
• CTA submissions and Competent Authority/Ethic Committee approvals
• CRF Design
• Recruitment of Patients or Healthy Volunteers
• Monitoring
• Quality Assurance
• Data Management
• Centralized laboratory
• ICU Access
• PK Analysis
• Statistical Analysis
• Clinical Study Report

For any inquiry regarding our services, please contact Biomapas Business Development team.

Biomapas works directly with clients to design feasibility studies that are tailored to the needs of a planned clinical trial or clinical research program. Each study includes both medical and regulatory review in order to identify study-related opportunities and risks in each country. For every project, a Feasibility Coordinator is appointed and supported by dedicated local CRAs, who manages feasibility studies in individual countries. The performance of such assessment allows us to find the optimal and most cost-effective solution for our clients.

INVESTIGATOR/SITE RECRUITMENT

Highly motivated investigators as well as timely and sufficient patient recruitment are crucial in order to succeed in every clinical trial. Biomapas has an extensive network of investigators, with long-standing relationships. This allows quick access to Key Opinion Leaders or Principal Investigators across a broad range of therapeutic indications and enables us to better predict the success rate of the clinical trial.

FEASIBILITY STUDY SERVICE

Strategic feasibility assessments that guide the site selection process and the recruitment planning include:

• First contact with potential investigators and a survey-based evaluation of their interest;
• Site qualification visits;
• Evaluation of potential patient pool in each country and in-depth analysis of patient recruitment associated risks;
• Analysis of competitive trials;
• Analysis of country-specific regulatory requirements, treatment practices, importation/exportation procedures, etc.;
• Assessment of patient and physician willingness to participate in the study;
• Assessment of sites capabilities and experience.

For any inquiry regarding our services, please contact Biomapas Business Development team.

Having solid experience in Clinical Trial Application (CTA) submissions and in-country personnel in over 20 countries across Europe and the CIS region, Biomapas provides a full-scope service in order to ensure the successful and timely start of a clinical study.

Our team is dedicated to delivering the highest quality support, providing the following services:

• Ethics Committee and Regulatory Authority submissions;
• Preparation of Informed Consent Forms (ICFs) in line with local requirements;
• Translation of all study-related documents into local languages, including quality check;
• Compilation of initial submissions, amendments, notifications and close-out submissions.

For any inquiry regarding our services, please contact Biomapas Business Development team.

Biomapas offers a tailored-service approach, taking into account the individual needs of our partners and the unique characteristics of each study. Biomapas Clinical Research Associates (CRAs) are dedicated to an average of 3 protocols at a time, empowering them to focus on excellence and quality assurance, understanding the intricate issues of the protocol and/or indication (disease), as well as ensuring site compliance. 

Our clinical monitoring team receives on-going training, to ensure they are completely up to date with current legislation, techniques and technologies.

Clinical monitoring services include, whilst not limited to:

• Country feasibility studies and site identification and assessment;
• Ethics committee and regulatory authority submissions; 
• Translation of study-specific documents including quality check; 
• Assistance in obtaining local insurance;
• Training of investigators and their teams (e.g. GCP, safety reporting, IMP handling, protocol, etc.);
• Clinical trial oversight in order to assure compliance with the protocol and applicable regulatory requirements;
• Accurate source verification for reliable clinical data;
• Site support on prompt recruitment process;
• File compilation, review and maintenance;
• Investigational Medicinal Product (IMP) and Clinical Trial Manager (CTM) coordination;
• Support during site audits and inspections.

For any inquiry regarding our services, please contact Biomapas Business Development team.

Biomapas provides comprehensive clinical project management services ranging from single-site studies to global registration trials. Our Project Managers maintain personal ownership of study milestones to ensure the projects are successful, delivered on time and completed within budget. Biomapas’ experienced, flexible and dedicated Project Managers lead all aspects of international and local clinical trials, providing continuous feedback on each step from start to finish. The responsibilities of our Project Managers include:

• Acting as the primary point of contact for our clients and the project team;
• Providing clinical development programme consulting and roadmapping for successful execution;
• Running in-depth feasibility studies and risk assessment plans for country evaluation, including regulatory environment, disease prevalence, and patient access;
• Creating a management framework to optimize project execution;
• Following-up on project risk management;
• Ensuring strict compliance to national standards, ICH GCP guidelines, EMA and FDA regulations, assigned SOPs and the trial protocol;
• Overseeing all functional areas and vendors;
• Managing site and sponsor communication.

For any inquiry regarding our services, please contact Biomapas Business Development team.

Biomapas quality and compliance assurance services help our clients to ensure the integrity of their clinical trials. In addition to providing in-house quality assurance auditing for clinical trial sites, CROs and third party vendors, we help our clients to protect research subjects’ rights and welfare, verify the integrity of data and ensure adherence to protocols and international regulatory guidelines. We provide a quality assurance audit service as part of a full-service or a stand-alone project. Our thorough assessment and objective recommendations help our clients and sites to develop the most effective actions to correct and prevent issues.

Biomapas is an ICH GCP investigator training provider, certified by the Lithuanian State Medicine Agency. Our GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial Sponsors.

Our Quality and Compliance services include:

• Clinical investigator site audits (Phase I/Bioequivalence facilities and clinical trials, Phase II-III clinical trials, post-marketing activities, routine, for-cause and pre-inspection audits to help sites prepare for regulatory agency reviews);
• Clinical study document audits and reviews;
• Clinical investigator site compliance visits;
• GCP and GVP quality system audits, in which we assess client internal processes, standard operating procedures (SOPs), staff training programs, as well as provide recommendations for improvement;
• Safety surveillance/pharmacovigilance audits;
• Vendor audits, assessments and qualifications, including GDP depot audits, in which we evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality based services on time and in compliance with regulations.

For any inquiry regarding our services, please contact Biomapas Business Development team.

Biomapas proactively solves potential Clinical Trial Materials, IMP Management process related issues and efficiently navigates challenging local import and export regulations. We have a well-established collaboration with local vendors in the service coverage area. The services include, whilst not limited to:

• Importation, storage and logistics of clinical trial supplies, i.e. investigational product, laboratory kits, i/v and p/o nutrition products, medical devices;
• Obtaining import and export license for investigational product;
• Obtaining import and export license for biological materials;
• Assistance with customs clearance;
• Ambient and cool area trial supply storage;
• Ambient and cold chain trial supply delivery;
• Trial supply relocation from site-to-site under controlled conditions;
• Bio-sample export management to central laboratory and vice versa;
• Collection, storage of returns and final reconciliation and destruction of stock inventory under controlled 24/7 temperature regimen.

For any inquiry regarding our services, please contact Biomapas Business Development team.

Data Management

Our Data Management team provides high-quality collection, organization, validation, analysis, and quality control of clinical trial data. Generally we utilize electronic data capture (EDC) to expedite data collection and enhance quality, but we can also handle paper CRFs (including printing, despatch, collection and double data entry). Services include:

• CRF Design, Edit Checks and Validation
• Data Management Plan
• EDC User Acceptance Testing
• EDC eLearning and Helpdesk
• Data Entry (for paper CRF or eDiary)
• Data Cleaning
• SAE Reconciliation
• Production of Listing for Medical Review
• Medical Coding
• Metrics/Tracking Report
• External Data Load (e.g. labs)
• Database Lock
• Database Transfer
• Patient Data Reports

Statistics

Biomapas skilled biostatisticians provide trial design consultation, statistical methodology recommendations, statistical programming and analysis to create a customized approach designed specifically to meet individual project requirements. Services include:

• Protocol and Statistical Analysis Plan development;
• Comprehensive data analysis plans including sample size determinations and power calculations;
• Detailed descriptions of statistical methodologies;
  
• Interpretation of study results and writing support for the preparation of interim analyses and study reports;
  
• Preparation of tables, listings and graphs including SDTM and ADaM compliant datasets;
  
• Integrated efficacy and safety analysis for regulatory submissions

For any inquiry regarding our services, please contact Biomapas Business Development team.

Our medical writers are qualified scientists with PhD degrees in biomedical sciences with experience in the pharmaceutical industry, Clinical Research Organizations (CROs) and academia. Biomapas’ medical writing team can fully support clients with the preparation of the following documents required for clinical research, regulatory affairs or scientific purposes:

• Clinical Development Plans;
• Clinical Study Protocols;
• Investigator Brochures (IBs) and annual updates;
• Case Report Forms (CRFs);
• Informed Consent Forms (ICFs);
• ICH GCP compliant Clinical Study Reports (CSRs), including CSR synopses for public disclosure;
• Abstracts, manuscripts and journal articles;
• Medical and scientific literature reviews.

For any inquiry regarding our services, please contact Biomapas Business Development team.