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GKM Gesellschaft für Therapieforschung mbH, München, Germany

GKM Gesellschaft für Therapieforschung mbH, München, Germany is listed as a mid sized business research supplier in the Scientist.com network, with 1 site in 1 country.

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Countries 1

Type of company: Mid sized business

Brand Communications

Patient-HCP Communication Aids Design and development of tools (visuals, guides, devices) that facilitate clear, accurate, and empathetic two-way dialogue between patients and their healthcare providers.

Clinical Consulting

Clinical Development Planning Complex document that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity.
Clinical Protocol Design & Development Creation of clinical protocol document which details how a clinical trial is designed, relating to to the methodology, hypothesis, and operation of clinical trial to ensure the safety of the patients is...
Clinical Study Reporting (CSR) Report results of clinical trials to regulatory agencies. This includes participant flow, baseline characteristics, outcome measures, statistical analyses, and adverse events.
Clinical Trial Consulting Consulting services for Clinical trials.
Clinical Trial Feasibility Request services related to Clinical Trial Design and feasibility.
Clinical Trial Recruitment Recruitment, enrollment and retention of patients for clinical trials.

Show all 10 in Clinical Consulting 4 more

Data & Risk Management Determine the extent of the risk and the reliability of the data used to access the aforementioned risk.
Orphan Disease Consulting FDA requires that an Investigational Review Board (IRB) must review all the documents related to the inclusion of participants within clinical trials. IRB is expected to review all the research documents...
Regulatory Compliance & Documentation Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.

Clinical Trials

Bioequivalence Studies Assess the expected biological equivalence of two proprietary preparations of a drug.
Case Report Monitoring & Auditing Ensure the adequate collection and traceability of clinical data in preparation for review by the FDA.
Central Institutional Review Board Services Ensure the safety and protection of human subjects participating in a study.
Central Laboratory Services A centralized facility that handles the processing and analysis of samples collected from multiple sites in a study.
Clinical Lab Services Comprehensive testing, analysis, and research support for a medical study.
Clinical Research Services Determine the safety and effectiveness of medications and medical devices.

Show all 42 in Clinical Trials 36 more

Clinical Trial Design Develop study-related protocols, case report forms (CRFs) and database tools for records management.
Clinical Trial Risk Management Plan that maintains treatment quality throughout lifecycle and improve decision making.
DCT Platform A digital environment designed to support and streamline decentralized clinical trials.
eCOA - Electronic Clinical Outcomes Assessments Use smartphones, computers and tablets to allow patients to directly report health outcomes.
eConsent - Electronic Informed Consent Monitor clinical trials through electronic informed consent given by patients.
EHR to EDC Transfer data from an Electronic Health Record (EHR) system to an Electronic Data Capture (EDC) system, which is commonly used in clinical trials
ePRO - Electronic Patient-reported Outcome Patient reported outcome collected by electronic methods.
Investigator Meeting Planning & Execution Investigator planning and meetings ensure that there is proper communication and reliability during a clinical trial. Allows for efficient work flow.
Investigator Recruitment Enlist clinical research experts to assist in investigator selection, recruitment monitoring and database evaluation.
IP Import/ Export Licensing Receive assistance with intellectual property import and export licensing.
IP Labeling Proper IP labeling guidelines are produced by the Food and Drug Association. Based on the compound or product in need of proper labelling there are guidelines that can be followed.
IP Packaging Proper packaging of pharmaceutical products and goods is crucial to ensure the validity and quality of the product being supplied. Proper investigational product packaging is aided by the use of quality...
IP Returns & Destruction Return the used and unused IP to the clinical trial sponsor for destruction, as well as send the used and unused IP for destruction in accordance with institution policy, or the standard operational procedure. Theses...
IP Shipments & Resupply IP shipments and resupply aid in the management of shipping of clinical trial material from warehouses to clinical sites, or vice versa. Shipping and resupply aids in restocking, drug orders, shipment tracking...
IP Storage IP storage protocols are specifically defined by the U.S. Pharmacopeia, Japanese Pharmacopeia, and the European Pharmacopeia that specifically define the proper storage and transportation conditions...
IRT Services IVRS and Drug supply services allow research conducting clinical trials to receive real time subject updates, drug supply and shipment tracking, and randomization for the clinical trial. These...
Patient Concierge Services Find a liaison between patients and healthcare providers, ensuring a smoother and more comfortable experience throughout the patient's journey.
Patient Recruitment Recruit and retain patients for clinical trials.
Patient Reimbursement and Travel Process individuals participating in clinical trials or receiving medical care are compensated for expenses related to travel, such as transportation, lodging, and meals
Pharmacokinetic Studies Design a study that observes the time course of drug absorption, distribution, metabolism, and excretion, as means to test the safety and effective therapeutic management of drugs in an individual patient.
Phase 1-3 Studies Design phase 1-3 studies that seek to identify if a drug is safe, effective, and more efficient than other available treatments on the market.
Post-Marketing (Phase 4) Studies Conduct phase 4 studies for confirming unrecognized safety issues, investigating possible hazards or establishing the expected safety profile of a veterinary medicinal product under market conditions.
Prospective Explorative Studies Conduct a prospective exploratory study to assess the safety and efficacy of a test drug during clinical trials.
Recruiting Healthy Volunteers Recruit volunteers who have no known significant health problems, and is willing and consenting to participate in research to test a new drug, device, or intervention.
Recruiting Special Populations Recruitment of volunteers who are categorized as part of a special population, or a protected part of the population such as the elderly, women, and children.
Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Regulatory Operations Ensure that all specific regulatory documents are published and properly organized before submission. 
Site Monitoring Maintain oversight over participant's health during a clinical trial.
Site Selection Select clinical trial sites with clinicians who recruit, enroll, treat and evaluate trial patients.
Site/Patient Payments Allow for different suppliers to organize the proper patient and site payments for a clinical trial. Provides real-time payments, reduce workloads for site staff and minimize the amount of time participants spend...
Statistical Analysis Planning Technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables...
Study/Site Feasibility Study Explore and test study practicality.
TeleHealth Delivery of healthcare services and information using electronic communication and information technologies, allowing for long-distance patient and clinician interactions
Trial Insights: Clinical Trials Intelligence Dashboard Trial Insights is the industry’s first digital research reporting dashboard made specifically to track ongoing clinical trials, observational, diagnostic and medical device studies. The solution aggregates and curates...
Virtual Clinical Trial Monitoring Platform This digital research platform allows researchers to monitor their clinical trials remotely.
Wearables / Remote Patient Monitoring Source medical-grade or consumer-grade devices that track patients' vital signs and other health data remotely and wirelessly transmit this information to healthcare providers

Show all 125 services 112 more

Creative

Case Studies Recruit research participants with a behavioral condition to receive either an investigational behavioral intervention or a behavioral intervention in clinical use.

Data Science/Bioinformatics

Biostatistical Design Use statistics to ensure appropriate pre-clinical and clinical study design.
Clinical Software Tools Software designed to serve the needs of clinical research groups.
Clinical Trial Integration Analysis The process of combining data from multiple clinical trials to understand categories of drugs and drug behavior in a more global way.

Drug Development

Consulting Services Work with consultants who provide expert advice in various areas of research and technology.

General Marketing

Database Management Software Facilitate the collection, tracking and processing of biological facts, statistics and observations.

HEOR

Clinical Outcome Assessments (Non-Patient Reported) Measure a patient's symptoms, mental state and level of disease condition-related impact on daily life.
Health Economics and Outcomes Research (HEOR) Evaluate data collected during drug development to maximize the value of a therapeutic product.

Human Biological Samples

HBS: Human Biological Samples Request human biosamples including tissues, blood, serum, bone marrow, tissue microarrays, etc.

Market Access

Health Technology Assessment (HTA) Preparation/Strategy Dossier Development Perform evidence preparation and/or create strategies for the systematic evaluation of the properties, effects, and/or impacts of health care technology.
Market Access - HTA Landscape Assessment Conduct a HTA landscape assessment to evaluate the direct and indirect impact of health technology on a specific region.
Market Access Materials Find general strategies and methods used to market a pharmaceutical product or device.

Medical Communications

Abstracts Request services related to the writing and review of abstracts
Adverse Events Reports Collecting, documenting, and forwarding reports of side effects or safety issues experienced by patients to the pharmacovigilance team for regulatory reporting.
Case Reviews Review medical cases from Clinical Trials.
Communication Plan Communications plan enables organizations and corporations to effectively deliver information to appropriate stakeholders and customers.
Data Visualization Visualize data collected from clinical trials and/or clinical research.
Delegate Logistics Managing the travel, accommodation, registration, and related administrative needs for attendees of investigator meetings, advisory boards, or congresses.

Show all 28 in Medical Communications 22 more

Distribution Strategy & Channel Recommendations Developing plans for how and where medical content (e.g., publications, training, MOA videos) will be efficiently delivered to the target healthcare audience.
KEE Identification, Mapping & Engagement Planning Systematic process to identify, categorize, and strategically plan outreach to Key External Experts (KEEs) based on their influence, specialization, and research activity.
Medical Affairs Dossiers Develop medical affairs dossiers such as Global Value Dossiers or AMCP Dossiers.
Medical letters, Emails & Customized Responses Drafting accurate, balanced, and compliant answers to unsolicited scientific and medical inquiries from healthcare professionals or consumers.
Medical Literature Reviews Systematic searching, appraisal, and synthesis of published scientific literature to generate evidence-based reports on a specific topic, disease, or treatment.
Medical Publications Make clear and accurate presentations of scientific and technical data.
Medical Q&As Developing pre-approved, standardized documents containing accurate, balanced answers to anticipated scientific inquiries about a product or disease.
Medical Science Liaison (MSL) External Presentation Develop and design Medical Science Liaison External Presentations.
Medical Science Liaison (MSL) Support Support services for Medical Science Liaisons (MSL).
Medical Science Liasion (MSL) Training Training for medical science liaisons who want to work in pharmaceutical, biotechnology, medical device, and managed care companies.
Patient Narratives Compliant collection and use of individual patient stories to illustrate the impact of a disease or treatment, often for training or empathy-building purposes.
Poster Design and Development Design and Develop Posters for Poster Symposiums and conferences to effectively convey science information.
Poster Symposia, Summits, Product Theaters, etc. Support Comprehensive planning and execution support for organized, large-scale medical meetings and events used to present and discuss clinical data and research.
Protocol and Study Reports Write protocol and study reports, specifically relating to the drafting, writing, and editing of Clinical Safety Reports.
Publication Writing Create further publication documents. Investigational device exemptions (IDEs) BLAs, MAA, PMA, eCTDs, informed consents, CMC and manufacturing reports, orphan drug designations (ODD), briefing books.
Publications Plan Development & Management Strategic planning and oversight of all research dissemination activities, including outlining target journals, timelines, authors, and compliance for clinical data publications.
Quality Control/ Quality Assurance Documents Develop quality control or quality assurance documents.
Regulatory Submissions and Compliance Draft, format, and submit documents to Pharmaceutical approval agencies according to documentation and guidelines. This includes documents such as NDAs, INDs, SUSARs, AE reporting, RMPs, and PSURS.
Review Article/ Submission Drafting and managing the process of submitting an objective, comprehensive summary of the current literature on a disease or treatment area to a peer-reviewed journal.
Sales Training Modules Develop and distribute sales training modules.
Sales Training Webinar Slide Decks Develop slide decks for sales training webinars.
Strategic Medical Communication Development & Planning High-level planning to define the core scientific messages and the tactical strategy needed to effectively convey clinical data to key stakeholders over time.

Medical/Commercial

Health & Pharmacoeconomics Identify, measure and compare the cost-benefit ratio of products and services.

Model Development

Juvenile Toxicology Assess developmental and reproductive defects due to neurobehavioral, skeletal and muscle growth effects.

Old Category HEOR, RWE, Market Access

Non-Interventional Studies Examine different aspects of drug usage, including efficacy and safety, under real-life conditions.
Patient-Reported Outcome Studies Get self-reported information regarding the personal health status of an individual.

Pharmacovigilance

Adverse Event (AE) and Serious Adverse Event (SAE) Reporting Report unfavourable and unintended events (e.g.: abnormal laboratory results, symptoms or disease associated with treatments) to regulatory bodies via the FDA's Adverse Event Reporting System (FAERS) or other...
Aggregate Safety Data Review Cumulative summary of safety information regarding the collection, analysis, and submission of aggregated safety data to health authorities at specified intervals.
GxP Compliance Monitoring Ensure products or services adhere to a set minimum standard.
Local Pharmacovigilance Support in International Markets Connect with Pharmacovigilance professionals to uphold the National pharmacovigilance guidelines and regulations.
Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report.
Pharmacovigilance Case Processing Collect, synthesize, and report adverse events (AE) and adverse drug reactions (ADR) data to allow for successful data analysis, scientific assessment and decision-making based on the safety data associated...

Show all 12 in Pharmacovigilance 6 more

Pharmacovigilance Literature Surveillance Conduct systematic and ongoing review of scientific and medical literature to identify new information about the safety profile of a drug. This process is crucial for detecting adverse drug reactions (ADRs) that may...
Pharmacovigilance Training and Education Training and education related to pharmacovigilance guidelines and adherence to EMA, FDA, and other regulatory bodies' documentation
Risk Management Plans (RMPs) Develop Risk Management plans (RMPs) that include information on a medicine's safety profile and plans for further pharmacovigilance activities designed to gain greater knowledge. These documents also explain how...
Safety Advisory Committees Collaborate with global experts to support safety surveillance monitoring and provide guidance on the safety of medicines and vaccines.
Safety Data Management Safety data management involves the collection, analysis, and reporting of data related to the safety of a drug. Including preparing and submitting safety reports to regulatory authorities, which may include periodic...
Signal Detection and Management Capture pre-determined safety signals or indicators from a variety of sources to ensure the safety of the product post clinical trial. This includes the review of various sources such as ICSRs, EVDAs, FAERS, and other...

Protein Sciences

Enzymology Enzymology studies the biochemical activity, structure, and function of enzymes. Two key area of Enzymology are Cytochrome P450...

Real World Evidence & Data

RWD - Rare Diseases Data from patients with rare diseases, can include clinical treatment, diagnosis, among others.
RWE/HEOR/Market Access Safety Surveillance Monitor safety of treatment and determine methods to identify adverse events early
RWE/RWD Observational Research Research method for documenting clinical, economic, and or humanistic outcomes of actual medical practice absent the constraints of a more formal experimental design. See also Pragmatic Clinical Trials.

Regulatory Affairs

Post Authorization Safety Study (PASS) Evaluate the safety, benefit-risk profile, and risk management of a treatment. These studies are specifically asked for by European Medicines Agency (EMA) and they can be mandatory or voluntary.
Post-authorization Safety Studies Research efforts conducted after a drug has been approved for market to monitor its safety profile in the general population. These studies aim to identify, characterize, or quantify potential adverse effects...
Regulatory Submission Documents Request services related to the submission and writing of New Drug Applications (NDA), Investigational New Drugs (INDs), and Investigator Brochures (IB) to the FDA and other regulatory bodies.

Safety Pharmacology

Abuse Liability Determine the dependence potential of a therapeutic.

Scientific Data Services

Data and Text Mining Derive structured data from free text in order to become accessible for data-mining algorithms.
Large Language Models Use of Large Language models in target discovery, clinical trial design and development, analysis of clinical trial data and regulatory submissions. Services are tailored to the problem, specific context of biopharma.

Other services

IND Writing Receive assistance with materials for an IND application.
NDA Writing Receive assistance in the NDA application process.
Plain Language Summaries Request services related to the creation of plain language summaries.
Rare Diseases Recruitment of volunteers or study participants who have a rare disease, or specifically in the "U.S.when a chronic and enervating condition afflicts fewer than 200,000 people combined, and in the EU, when it affects...
Site Management Organizations Site Management Organization (SMO) is an organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device...
Trial Awareness Create awareness about a clinical trial.

Website: www.gkm-therapieforschung.de/en

Germany Munich 1 site

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