Clinical Research

A full-scope partner in clinical development that accelerates your path to market.

Exceeding your timelines isn’t chance. It’s our mindset.

Early clinical development experts with one-stop-shop capabilities in high recruiting countries, accelerating product path to the market. We are particularly strong in Eastern Europe and the CIS region, where patient recruitment is fast and reliable. Investigators are keen to participate in trials thanks to less competition and more treatment naïve patients.

Our Early Phase Unit BIO1 offers a safe and comfortable environment for patients or healthy volunteers. It provides each customer with a project manager as a principal point of contact who oversees the process from recruitment to clinical study reports. The facility covers all types of early phase clinical studies, including first-in-human and proof-of-concept, single and multiple doses, bioequivalence, bioavailability, drug-drug and drug-food interaction, PK/PD, tQTc studies.

Clinical Research
Clinical Strategy Early Phase Phase II Phase III Post-Marketing Rescue Studies Authority Interaction

Clinical Strategy

For your trials to be successful, you need to be well-versed in science and technology.  Knowing there is no one-size-fits-all approach to clinical development, we apply an integrated approach to development that leverages our different in-house disciplines. Biomapas' goal is to help you face increasing R&D costs, shorter product lifecycles, and embrace digital transformation in clinical development.

Early Phase

Early Phase Research Unit (BIO1) at Biomapas offers patients and healthy volunteers a comfortable and secure setting. To make things easier for its customers, we assign a project manager to everyone who supervises everything from recruiting to clinical study results.  BIO1's capabilities include:

  • first-in-human and proof-of-concept;
  • single and multiple doses;
  • bioequivalence;
  • bioavailability;
  • drug-drug and drug-food interaction;
  • PK/PD;
  • tQTc studies. 

Phase II

As part of our efforts to assist you to comprehend the complexities of Phase II and III clinical trials, we create unique recruitment strategies for you, engage medical writers, and manage clinical sites to support you. Wherever you are in the world, our clinical project managers keep you informed at every step. While looking for appropriate patients in the EU and Developing Markets, you may benefit from our strong KOL network and patient access.

Rescue Studies

Whatever the situation, Biomapas can help you finish your studies on schedule, improve the quality of your trials, or have your research approved again by a regulatory body.

 

Your research duration, regulatory filings and ultimate commercialization are all affected by these variables. As a result, after evaluating the extent and kind of study management deficit and identifying the sort of repair needed, we may act as a third-party function.

Authority Interaction

During drug development, marketing authorization, or later in the medication's lifecycle, interactions with health authorities may impact your product's outcome and financial success. Meetings with health authorities allow you to fine-tune your development plan with feedback from potential marketing authorization decision-makers. Biomapas prepares you to get the most out of them and informs you of the authorities' priorities, questions, and expectations.

Early Phase Unit

BIO1 is Biomapas’ early phase unit located in Lithuania’s leading university hospital-Vilnius University Hospital, Santaros Clinics (over 2000 beds).

BIO1 offers a safe and comfortable environment for patients or healthy volunteers. It provides each customer with a project manager as a principal point of contact who oversees the whole process from recruitment to clinical study reports. The facility covers all types of early phase clinical studies, including first-in-human and proof-of-concept, single and multiple doses, bioequivalence, bioavailability, drug-drug and drug-food interaction, PK/PD, tQTc studies.

Patient Studies

Healthy Volunteer Studies

 

 

 

 

 

 

 

 

 

 

Clinical Development

We provide full-service solutions for early drug development and medical devices. We have clinical experts in over 20 countries and experience in the following therapeutic areas: oncology, CNS, cardiovascular, infectious disease, immunology, rheumatology, pulmonology, endocrinology, gynecology, gastroenterology, nephrology, ophthalmology, urology and dermatology.

Early Phase Development

Phase II – III

Rescue Studies

 

Functional Service Provision

Biomapas’ Clinical Development experts are enthusiastic about scaling your clinical trial resources, accelerating timelines, and maximizing efficiency throughout your Clinical Research programs.

It doesn’t matter if you need a single expert or an entire clinical team, we look forward to exceeding your expectations and drive performance and efficiency for you, too.

 

 

 

 

 

 

Study design & protocol development

Strategic Feasibility

Regulatory & Ethics Committee Submissions

Project Management

Clinical Monitoring & Site Management

Clinical Safety & Pharmacovigilance

Medical Monitoring

Quality & Compliance

Early Phase Unit

Geographical reach

Early Phase Unit

BIO1 is Biomapas’ early phase unit located in Lithuania’s leading university hospital-Vilnius University Hospital, Santaros Clinics (over 2000 beds).

BIO1 offers a safe and comfortable environment for patients or healthy volunteers. It provides each customer with a project manager as a principal point of contact who oversees the whole process from recruitment to clinical study reports. The facility covers all types of early phase clinical studies, including first-in-human and proof-of-concept, single and multiple doses, bioequivalence, bioavailability, drug-drug and drug-food interaction, PK/PD, tQTc studies.

Patient Studies

Healthy Volunteer Studies

 

Clinical Development

We provide full-service solutions for early drug development and medical devices. We have clinical experts in over 20 countries and experience in the following therapeutic areas: oncology, CNS, cardiovascular, infectious disease, immunology, rheumatology, pulmonology, endocrinology, gynecology, gastroenterology, nephrology, ophthalmology, urology and dermatology.

Early Phase Development

Phase II – III

Rescue Studies

Functional Service Provision

Biomapas’ Clinical Development experts are enthusiastic about scaling your clinical trial resources, accelerating timelines, and maximizing efficiency throughout your Clinical Research programs.

It doesn’t matter if you need a single expert or an entire clinical team, we look forward to exceeding your expectations and drive performance and efficiency for you, too.

Study design & protocol development

Strategic Feasibility

Regulatory & Ethics Committee Submissions

Project Management

Clinical Monitoring & Site Management

Clinical Safety & Pharmacovigilance

Medical Monitoring

Quality & Compliance

Early Phase Unit

Geographical reach

Therapeutic Expertise

With two decades of experience while working with clinical development Biomapas has gathered experience in numerous therapeutic areas throughout various stages of pharmaceuticals, biologicals and medical devices development lifecycle.

Clinical Trial Professionals

Clinical Trials Completed In Last 5 Years

Patients Randomized In Last 5 Years

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Sponsors Choose Us For Next Project

Biotech

We have all needed in-house facilities and expertise to investigate novel biotech products. 

High Recruitment Rates

In the CEE we can generally guarantee easy access to patients and healthy volunteers.

Oncology Expertise

 Experience in numerous therapeutic areas but a keen focus on Oncology drug products.

Blog

Clinical Study Start-Up: Differences Between West & East Europe.

This article reviews different parts of a clinical trial, the start-up phase, its timelines in France, Germany, Poland, and the Baltic states, and examines the processes and compares them in-between these countries.

A partner that is dedicated to you and understands the challenges you face. 

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Regina Auškalnienė

Regina Auškalnienė

Chief Global Clinical Research

Regina Auškalnienė is a Medical Doctor, a cardiologist with over 13 years of experience in Clinical Research gained at one of the world’s largest CROs. Since 2018, she leads Biomapas’ Clinical Research department, overseeing Clinical Monitoring, Project Management, and Start-up activities.