Clinical trials are often seen as a regulatory necessity, but for biotech and medtech startups, they can be much more.…
Axcellant participated in SNMMI’s 2025 Annual Meeting in New Orleans, where nearly 8,000 professionals in nuclear medicine and molecular imaging gathered…
Axcellant participated in the PET Symposium 2025, held in Turku, marking 50 years of PET radiochemistry at the Turku PET…
The EU is moving forward with key upgrades to its medical device and diagnostics regulations, specifically under the Medical Device…
Gene therapies now account for most ATMP clinical trials, with a balanced distribution between in vivo and ex vivo approaches.…
Academic medical centers in the US are voicing concern over reduced funding from the National Institutes of Health (NIH). While…
What Does the 'Statistical Analysis Plan (SAP)' Mean? A Statistical Analysis Plan (SAP) is a comprehensive document that outlines the…
What Does the 'Strategic Outsourcing' Mean? Strategic outsourcing refers to the practice of contracting out specific business functions or processes…
What Does the 'Stratification' Mean? Stratification in clinical research refers to the process of dividing study participants into subgroups based…
What Does the 'Study Nurse' Mean? A study nurse, also known as a clinical research nurse, is a healthcare professional…
What Does the 'Study Start-Up Specialist' Mean? A Study Start-Up Specialist is a professional responsible for managing the initial phases…
What Does the 'Study Startup' Mean? Study startup refers to the initial phase of a clinical trial that encompasses all…
What Does the 'Subgroup Analysis' Mean? Subgroup analysis refers to the examination of treatment effects within specific subsets of participants…
What Does the 'Subject Retention' Mean? Subject retention refers to the process of keeping participants enrolled and actively engaged in…
What Does the 'Superiority Trial' Mean? A superiority trial is a type of clinical study designed to demonstrate that one…
What Does the 'Telemedicine' Mean? Telemedicine refers to the practice of providing healthcare services remotely using telecommunications technology. It involves…
What Does the 'Therapeutic Area Expertise' Mean? Therapeutic Area Expertise refers to specialized knowledge and experience in a specific medical…
What Does the 'Third-Party Risk Management' Mean? Third-Party Risk Management refers to the process of identifying, assessing, and controlling potential…
What Does the 'Time to Market' Mean? Time to Market refers to the duration between the conception of a product…
What Does the 'Training Compliance' Mean? Training compliance refers to the adherence of clinical research personnel to required training programs…
What Does the 'Translational Medicine' Mean? Translational medicine refers to the process of turning scientific discoveries into practical applications that…
What Does the 'Trial Master File (TMF)' Mean? A Trial Master File (TMF) is a comprehensive collection of essential documents…
What Does the 'Trial Oversight Committee' Mean? A Trial Oversight Committee is a group of individuals responsible for monitoring and…
What Does the 'UDI (Unique Device Identification)' Mean? UDI, or Unique Device Identification, is a system used to mark and…
What Does the 'Usability Testing' Mean? Usability testing is a research method used to evaluate how easily users can interact…
What Does the 'Vendor Oversight Plan' Mean? A Vendor Oversight Plan is a documented strategy for managing and monitoring external…
What Does the 'Vendor Qualification' Mean? Vendor qualification refers to the process of evaluating and approving suppliers or service providers…
What Does the 'Virtual Site' Mean? A virtual site in clinical research refers to a decentralized approach to conducting clinical…
What Does 'Audit Trail' Mean? An audit trail is a chronological record of activities and events related to a clinical…
What Does 'Bayesian Design' Mean? Bayesian design refers to a statistical approach used in clinical trials that incorporates prior knowledge…
What Does 'Benefit-Risk Assessment' Mean? Benefit-risk assessment is a systematic approach used in clinical research and drug development to evaluate…
What Does 'Biostatistician' Mean? A biostatistician is a professional who applies statistical methods and principles to biological and health-related research.…
What Does 'Biostatistics' Mean? Biostatistics refers to the application of statistical methods to biological data and problems in the life…
What Does 'BLA (Biologics License Application)' Mean? A Biologics License Application (BLA) is a request for permission to introduce, or…
What Does 'Blinded Study' Mean? A blinded study is a clinical research design where one or more parties involved in…
What Does 'BYOD (Bring Your Own Device)' Mean? BYOD, or Bring Your Own Device, refers to the practice of allowing…
What Does 'CAPA (Corrective and Preventive Action)' Mean? CAPA, which stands for Corrective and Preventive Action, is a systematic approach…
What Does 'Case Processing' Mean? Case processing refers to the systematic handling and management of individual participant data in clinical…
What Does 'Causality Assessment' Mean? Causality assessment is the process of evaluating the relationship between an adverse event and a…
What Does 'CE Marking' Mean? CE Marking is a certification mark that indicates conformity with health, safety, and environmental protection…
What Does 'Class I Device' Mean? A Class I device is a medical device classification defined by regulatory agencies such…
What Does 'Class IIa / IIb Device' Mean? Class IIa and IIb devices are categories of medical devices under the…
What Does 'Class III Device' Mean? A Class III device is a category of medical device that carries the highest…
What Does 'Clinical Database' Mean? A clinical database is a structured collection of data specifically designed to store, manage, and…
What Does 'Clinical Evaluation Report (CER)' Mean? A Clinical Evaluation Report (CER) is a comprehensive document that assesses the safety…
What Does 'Clinical Hold' Mean? A clinical hold is a regulatory action taken by the U.S. Food and Drug Administration…
What Does 'Clinical Operations' Mean? Clinical Operations refers to the management and execution of clinical trials in the pharmaceutical, biotechnology,…
What Does 'Clinical Research Associate (CRA)' Mean? A Clinical Research Associate (CRA) is a healthcare professional who oversees and monitors…
What Does 'Clinical Study Report (CSR)' Mean? A Clinical Study Report (CSR) is a comprehensive document that provides a detailed…
What Does 'Clinical Supply Management' Mean? Clinical Supply Management refers to the process of planning, manufacturing, packaging, labeling, and distributing…
What Does 'Clinical Trial Agreement (CTA)' Mean? A Clinical Trial Agreement (CTA) is a legally binding contract between the sponsor…
What Does 'Clinical Trial Assistant (CTA)' Mean? A Clinical Trial Assistant (CTA) is a professional who provides administrative and operational…
What Does 'Clinical Trial Monitor' Mean? A Clinical Trial Monitor, also known as a Clinical Research Associate (CRA), is a…
What Does 'Clinical Trial Protocol' Mean? A clinical trial protocol is a detailed document that outlines the objectives, design, methodology,…
What Does 'Close-Out Visit' Mean? A close-out visit is the final on-site monitoring visit conducted at a clinical trial site…
What Does 'Cold Chain Logistics' Mean? Cold chain logistics refers to the temperature-controlled supply chain process used to maintain product…
What Does 'Companion Diagnostic' Mean? A companion diagnostic is a medical device, often an in vitro diagnostic test, that provides…
What Does 'Competitive Intelligence' Mean? Competitive Intelligence refers to the process of gathering, analyzing, and interpreting information about competitors, markets,…
What Does 'Confidence Interval' Mean? A confidence interval is a range of values that likely contains the true population parameter…
What Does 'CTD (Common Technical Document)' Mean? CTD stands for Common Technical Document, which is a standardized format for organizing…
What Does 'Data Cleaning' Mean? Data cleaning refers to the process of identifying and correcting errors, inconsistencies, and inaccuracies in…
What Does 'Data Entry Guidelines' Mean? Data Entry Guidelines refer to a set of standardized instructions and protocols for inputting…
What Does 'Data Management Plan (DMP)' Mean? A Data Management Plan (DMP) is a formal document that outlines how research…
What Does 'Data Manager' Mean? A Data Manager in clinical research is a professional responsible for overseeing the collection, organization,…
What Does 'Data Monitoring Committee (DMC)' Mean? A Data Monitoring Committee (DMC), also known as a Data Safety Monitoring Board…
What Does 'Data Privacy' Mean? Data privacy refers to the protection and proper handling of personal or sensitive information collected…
What Does 'Data Quality Review' Mean? Data Quality Review refers to the systematic process of examining and evaluating the accuracy,…
What Does 'Data Reconciliation' Mean? Data reconciliation in clinical research refers to the process of comparing and verifying data from…
What Does 'Decentralized Clinical Trial (DCT)' Mean? A Decentralized Clinical Trial (DCT) is a study model that leverages technology and…
What Does 'Development Safety Update Report (DSUR)' Mean? A Development Safety Update Report (DSUR) is a comprehensive annual review of…
What Does 'Deviation Management' Mean? Deviation management refers to the process of identifying, documenting, evaluating, and addressing departures from approved…
What Does 'Device Master Record' Mean? A Device Master Record (DMR) is a comprehensive compilation of documents that describes the…
What Does 'Device Vigilance' Mean? Device vigilance refers to the systematic monitoring and evaluation of medical devices after they have…
What Does 'Digital Endpoint' Mean? A digital endpoint refers to a measure of health or disease status that is collected…
What Does 'Direct-to-Patient (DTP)' Mean? Direct-to-Patient (DTP) refers to a clinical trial approach where study medications and supplies are delivered…
What Does 'Document Specialist' Mean? A Document Specialist is a professional responsible for managing and organizing documentation within a clinical…
What Does 'Double-Blind Trial' Mean? A double-blind trial is a type of clinical study design where both the participants and…
What Does 'Drug Lifecycle Management' Mean? Drug Lifecycle Management refers to the strategic planning and execution of activities throughout a…
What Does 'eCRF (Electronic Case Report Form)' Mean? An eCRF, or Electronic Case Report Form, is a digital version of…
What Does 'EDC (Electronic Data Capture)' Mean? EDC, or Electronic Data Capture, refers to a computerized system used in clinical…
What Does 'Endpoint Hierarchy' Mean? Endpoint hierarchy refers to the organization and prioritization of outcome measures in a clinical trial.…
What Does 'Enrollment Rate' Mean? Enrollment rate refers to the speed at which participants are recruited and included in a…
What Does the 'ePRO (Electronic Patient-Reported Outcomes)' Mean? ePRO stands for Electronic Patient-Reported Outcomes, referring to health-related data directly reported…
What Does the 'Essential Documents' Mean? Essential documents in clinical research refer to the core records that individually and collectively…
What Does the 'Ethics Approval' Mean? Ethics approval refers to the formal authorization granted by an ethics committee or institutional…
What Does the 'Exploratory Endpoint' Mean? An exploratory endpoint is a measure or outcome in a clinical trial that is…
What Does the 'Functional Service Provider (FSP)' Mean? A Functional Service Provider (FSP) is a specialized outsourcing model used in…
What Does the 'GCP (Good Clinical Practice)' Mean? GCP, or Good Clinical Practice, is an international ethical and scientific quality…
What Does the 'GLP (Good Laboratory Practice)' Mean? GLP, or Good Laboratory Practice, refers to a quality system of management…
What Does the 'GMP (Good Manufacturing Practice)' Mean? GMP, or Good Manufacturing Practice, refers to a system of quality assurance…
What Does the 'Health Economics and Outcomes Research (HEOR)' Mean? Health Economics and Outcomes Research (HEOR) is a multidisciplinary field…
What Does the 'Home Health Visits' Mean? Home health visits refer to medical care services provided to patients in their…
What Does the 'IEC (Independent Ethics Committee)' Mean? An Independent Ethics Committee (IEC) is a group responsible for reviewing and…
What Does the 'IMP Accountability' Mean? IMP Accountability refers to the process of tracking and documenting the lifecycle of an…
What Does the 'Import/Export Licensing' Mean? Import/Export Licensing refers to the official permissions required to bring goods into a country…
What Does the 'IND (Investigational New Drug)' Mean? An IND, or Investigational New Drug, refers to a new drug, biologic,…
What Does the 'Independent Endpoint Adjudication Committee (IEAC)' Mean? An Independent Endpoint Adjudication Committee (IEAC) is a group of experts…
What Does the 'Informed Consent Form (ICF)' Mean? An Informed Consent Form (ICF) is a crucial document used in clinical…
What Does the 'Informed Consent Process' Mean? The informed consent process is a crucial ethical and legal procedure in clinical…
What Does the 'Inspection Readiness' Mean? Inspection readiness refers to the state of preparedness a clinical research organization or sponsor…
What Does the 'Intention-to-Treat (ITT)' Mean? Intention-to-Treat (ITT) is a principle used in the design and analysis of randomized controlled…
What Does the 'Interactive Response Technology (IRT)' Mean? Interactive Response Technology (IRT) refers to systems used in clinical trials to…
What Does the 'Interim Analysis' Mean? An interim analysis refers to a planned examination of data from an ongoing clinical…
What Does the 'Interim Monitoring Visit (IMV)' Mean? An Interim Monitoring Visit (IMV) is a scheduled on-site evaluation conducted during…
What Does the 'Investigational Product (IP)' Mean? An Investigational Product (IP) refers to a pharmaceutical form of an active ingredient…
What Does the 'Investigator' Mean? An investigator in clinical research refers to a qualified individual who is responsible for conducting…
What Does the 'Investigator Site File (ISF)' Mean? The Investigator Site File (ISF) is a comprehensive collection of essential documents…
What Does the 'Investigator's Brochure (IB)' Mean? An Investigator's Brochure (IB) is a comprehensive document that summarizes the clinical and…
What Does the 'IRB (Institutional Review Board)' Mean? An Institutional Review Board (IRB) is an independent committee established to review…
What Does the 'Issue Escalation' Mean? Issue escalation refers to the process of elevating a problem or concern to a…
What Does the 'IVDR (In Vitro Diagnostic Regulation)' Mean? IVDR stands for In Vitro Diagnostic Regulation, which is a set…
What Does the 'KPIs in Clinical Trials' Mean? KPIs in clinical trials stands for Key Performance Indicators. These are measurable…
What Does the 'Labeling Requirements' Mean? Labeling requirements refer to the specific guidelines and regulations that govern how pharmaceutical products,…
What Does the 'Literature Screening' Mean? Literature screening refers to the systematic process of reviewing and evaluating published scientific literature…
What Does the 'Market Access' Mean? Market access refers to the process of ensuring that new pharmaceutical products or medical…
What Does the 'Master Service Agreement (MSA)' Mean? A Master Service Agreement (MSA) is a contract that establishes the fundamental…
What Does the 'MDR (Medical Device Regulation)' Mean? MDR stands for Medical Device Regulation, which is a set of rules…
What Does the 'Mechanism of Action (MoA)' Mean? Mechanism of Action (MoA) refers to the specific biochemical interaction through which…
What Does the 'Medical Coding' Mean? Medical coding is the process of transforming healthcare diagnoses, procedures, medical services, and equipment…
What Does the 'Medical Evaluation' Mean? A medical evaluation refers to a comprehensive assessment of a patient's health status conducted…
What Does the 'Medical Monitor' Mean? A Medical Monitor is a physician who oversees the safety aspects of a clinical…
What Does the 'Medical Reviewer' Mean? A Medical Reviewer is a healthcare professional, typically a physician or pharmacist, who evaluates…
What Does the 'Medical Writer' Mean? A medical writer is a professional who creates scientific and healthcare-related documents for various…
What Does the 'Medical Writing' Mean? Medical writing refers to the process of creating clear, accurate, and scientifically sound documents…
What Does the 'Missing Data' Mean? Missing data refers to information that is not available for a particular observation or…
What Does the 'Mode of Administration' Mean? Mode of administration refers to the method by which a medication or treatment…
What Does the 'Monitoring Visit' Mean? A monitoring visit is an on-site evaluation conducted by a clinical research associate (CRA)…
What Does the 'Narrative Writing' Mean? Narrative writing refers to the process of creating a story or account of connected…
What Does the 'NDA (New Drug Application)' Mean? An NDA, or New Drug Application, is a formal request submitted to…
What Does the 'Non-Inferiority Trial' Mean? A non-inferiority trial is a type of clinical study designed to demonstrate that a…
What Does the 'Nonclinical Study' Mean? A nonclinical study refers to research conducted on non-human subjects to gather data on…
What Does the 'Notified Body' Mean? A Notified Body is an organization designated by an EU country to assess the…
What Does the 'Oversight Log' Mean? An oversight log is a document used in clinical research to record and track…
What Does the 'Patient Engagement Platform' Mean? A Patient Engagement Platform is a digital tool or system designed to facilitate…
What Does the 'Per Protocol Analysis' Mean? Per Protocol Analysis is a method of analyzing clinical trial data that includes…
What Does the 'Performance Evaluation Plan' Mean? A Performance Evaluation Plan is a structured approach to assessing the effectiveness and…
What Does the 'Periodic Safety Update Report (PSUR)' Mean? A Periodic Safety Update Report (PSUR) is a pharmacovigilance document submitted…
What Does the 'Pharmacovigilance Agreement (PVA)' Mean? A Pharmacovigilance Agreement (PVA) is a formal contract between two or more parties…
What Does the 'Pharmacovigilance Officer' Mean? A Pharmacovigilance Officer is a healthcare professional responsible for monitoring and assessing the safety…
What Does the 'Placebo-Controlled Study' Mean? A placebo-controlled study is a type of clinical trial where a group of participants…
What Does the 'Portfolio Optimization' Mean? Portfolio optimization refers to the process of selecting the best combination of clinical trials…
What Does the 'Power of a Study' Mean? The power of a study refers to the probability that a statistical…
What Does the 'Primary Endpoint' Mean? A primary endpoint is the main outcome measure used to evaluate the effectiveness or…
What Does the 'Principal Investigator (PI)' Mean? A Principal Investigator (PI) is the lead researcher responsible for the overall conduct…
What Does the 'Project Manager' Mean? A Project Manager in clinical research is a professional responsible for overseeing and coordinating…
What Does the 'Protocol Amendment' Mean? A protocol amendment refers to a formal, documented change made to a clinical trial…
What Does the 'Protocol Deviation' Mean? A protocol deviation refers to any departure from the approved study protocol in a…
What Does the 'QPPV (Qualified Person Responsible for Pharmacovigilance)' Mean? QPPV stands for Qualified Person Responsible for Pharmacovigilance. This role…
What Does the 'Quality Auditor' Mean? A Quality Auditor is a professional responsible for evaluating and assessing the quality management…
What Does the 'Quality Management System (QMS)' Mean? A Quality Management System (QMS) is a formalized system that documents processes,…
What Does the 'Quality Tolerance Limits (QTLs)' Mean? Quality Tolerance Limits (QTLs) are predetermined thresholds or boundaries established for critical…
What Does the 'Query Resolution' Mean? Query resolution refers to the process of addressing and clarifying questions or inconsistencies that…
What Does the 'Randomization' Mean? Randomization in clinical research refers to the process of assigning participants to different treatment groups…
What Does the 'Randomization & Trial Supply Management (RTSM)' Mean? Randomization & Trial Supply Management (RTSM) refers to a critical…
What Does the 'Real-World Evidence (RWE)' Mean? Real-World Evidence (RWE) refers to clinical evidence regarding the usage and potential benefits…
What Does the 'Reconciliation of IP' Mean? Reconciliation of IP, in clinical research, refers to the process of accounting for…
What Does the 'Regulatory Affairs Associate' Mean? A Regulatory Affairs Associate is a professional who ensures compliance with regulatory requirements…
What Does the 'Regulatory Intelligence' Mean? Regulatory Intelligence refers to the systematic and continuous process of gathering, analyzing, and disseminating…
What Does the 'Regulatory Submission' Mean? A regulatory submission refers to the process of formally presenting data, documentation, and other…
What Does the 'Remote Data Review' Mean? Remote Data Review refers to the process of examining and evaluating clinical trial…
What Does the 'Remote Source Access' Mean? Remote Source Access refers to the ability to view, retrieve, or interact with…
What Does the 'Risk Management Plan (RMP)' Mean? A Risk Management Plan (RMP) is a comprehensive document that outlines the…
What Does the 'SAE (Serious Adverse Event)' Mean? SAE stands for Serious Adverse Event in clinical research. It refers to…
What Does the 'Safety Physician' Mean? A Safety Physician is a medical professional responsible for overseeing the safety aspects of…
What Does the 'Sample Size Calculation' Mean? Sample size calculation refers to the process of determining the number of participants…
What Does the 'Scientific Advice' Mean? Scientific advice refers to the formal process of seeking guidance from regulatory authorities or…
What Does the 'Screen Failure' Mean? Screen failure refers to a situation in clinical trials where a potential participant does…
What Does the 'Secondary Endpoint' Mean? A secondary endpoint is an additional outcome measure in a clinical trial that is…
What Does the 'Service Level Agreement (SLA)' Mean? A Service Level Agreement (SLA) is a formal contract between a service…
What Does the 'Shipment Documentation' Mean? Shipment documentation refers to the collection of records and forms that accompany clinical trial…
What Does the 'Signal Detection' Mean? Signal detection in clinical research refers to the process of identifying and analyzing potential…
What Does the 'Site Activation' Mean? Site activation refers to the process of preparing and authorizing a clinical research site…
What Does the 'Site Coordinator' Mean? A Site Coordinator is a key professional in clinical research who manages the day-to-day…
What Does the 'Site Feasibility' Mean? Site feasibility refers to the process of evaluating a potential clinical trial site's capability…
What Does the 'Site Initiation Visit (SIV)' Mean? A Site Initiation Visit (SIV) is a crucial meeting that takes place…
What Does the 'Site Monitoring Plan' Mean? A Site Monitoring Plan is a comprehensive document that outlines the strategy and…
What Does the 'Site Selection' Mean? Site selection refers to the process of identifying, evaluating, and choosing appropriate locations or…
What Does the 'Software as a Medical Device (SaMD)' Mean? Software as a Medical Device (SaMD) refers to software intended…
What Does the 'Solicited Report' Mean? A solicited report refers to safety information collected in a systematic manner through organized…
What Does the 'Source Data Verification (SDV)' Mean? Source Data Verification (SDV) is a crucial quality control process in clinical…
What Does the 'Sponsor Obligations' Mean? Sponsor obligations refer to the legal and ethical responsibilities that a clinical trial sponsor…
What Does the 'Spontaneous Report' Mean? A spontaneous report is an unsolicited communication by a healthcare professional or consumer to…
Robust clinical trial data are proving to be fundamental in shaping investor confidence and driving strategic decisions in the biotechnology…
Between 2015 and 2020, over 200 AI/ML-enabled medical devices received regulatory approval in the US and EU, with a strong…
In a recent article published by My Company Polska—one of Poland's leading business magazines—the untapped potential of mushrooms took center…
Axcellant is excited to announce our participation at the European Association of Nuclear Medicine (EANM) Congress in Hamburg from October…
At March’s online “Racjonalny Inwestor” conference hosted by StockWatch.pl, our CEO, Wojciech Kula, joined a panel discussion on a key…
Over the past two decades, the Polish CRO industry has transformed dramatically. What began with simple monitoring tasks has evolved…
The clinical research market in Poland has experienced remarkable growth, expanding from an estimated €200 million a decade ago to…
Marking a significant achievement in our ongoing efforts to advance medical device research, we have successfully concluded a PMCF study…
Initiating a clinical trial is akin to embarking on a voyage of discovery in the realm of medicine. This journey,…
Our team at Axcellant is proud to announce the completion of a significant Post-Market Clinical Follow-up study. This study was…
In the ever-evolving realm of pharmaceuticals and healthcare, a remarkable transformation is afoot - one that's reshaping the way we…
Clinical research is a complex and multifaceted field that relies on the dedicated efforts of a diverse team to bring…
Meet our team at top Nuclear Medicine Event – SNMMI in Chicago, 24 - 27 June 2023.
Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children.
From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS).
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to...
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