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Coronado Research

Coronado Research is listed as a small business research supplier in the Scientist.com network, with 1 site in 1 country.

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Type of company: Small business

Biomarkers

Digital Biomarkers Objective, quantifiable physiological and behavioral data that are collected and measured by means of digital devices such as portables, wearables, implantables, or digestibles.

Brand Communications

Brand Messaging Brand messaging is the strategic use of language, tone, and storytelling to communicate a company’s identity, core values, and unique value proposition to its target audience
Brand Positioning The strategic process of designing a company’s offering and image to occupy a distinctive, valuable place in the minds of your target audience.
Disease Awareness Educate people about specific medical conditions, including their symptoms, risk factors, and available treatments
Launch Campaign A launch campaign is a coordinated marketing push designed to introduce a new product, service, or brand to the market, build audience anticipation, and drive sales
Multi-Channel Marketing Multi-channel marketing
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

Biometrics Consulting Apply statistics and mathematics to drug discovery, clinical trials, and data analysis.
Biostatistics Consulting Apply statistical theory and mathematical principals to research
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.
Data & Risk Management Determine the extent of the risk and the reliability of the data used to access the aforementioned risk.
Medical Communications Materials Mediate general correspondence and answer inquiries from participants in clinical trials.

Show all 9 in Clinical Consulting 3 more

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.
Study Budgeting Consulting Request for Consulting Services

Show all 207 services 194 more

Clinical Trials

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.
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
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.
Protocol Optimization via AI/ML Using of artificial intelligence and machine learning techniques to enhance and streamline experimental protocols or operational procedures for improved efficiency, accuracy, and outcomes.
Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.

Show all 9 in Clinical Trials 3 more

Regulatory Operations Ensure that all specific regulatory documents are published and properly organized before submission. 
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...
Synthetic Control Arm Creation Using RWD Using patient data from sources like electronic health records or claims databases to construct a comparator group for clinical trials, instead of enrolling a separate group of control patients.

Commercial Consulting

Portfolio Management Manage a portfolio of projects in early-stage drug discovery and provide factors that determine the success of the proposed portfolio.

Creative

Infographic Create a quick visual representation of information, data or knowledge.

Data Science/Bioinformatics

Biostatistical Design Use statistics to ensure appropriate pre-clinical and clinical study design.
Clinical Data Analysis Analysis that helps you make sense of your clinical data
Clinical Data Management A process that includes acquiring, validating, storing, protecting, and processing required data to ensure the accessibility, reliability, and timeliness of the data.
Clinical Data Science and Modeling A process that helps make sense of your clinical data
Clinical Machine Learning/AI Complex analytical approaches to find patterns and make predictions in drug discovery projects
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.

Show all 16 in Data Science/Bioinformatics 10 more

FAIR data strategy consulting FAIR data strategy consulting involves guiding organizations to adopt data management practices that ensure their data is Findable, Accessible, Interoperable, and Reusable, thereby enhancing data usability and value.
Graph-Based Patient Journey Analysis Graph-based patient journey analysis is a method of visualizing and analyzing the pathways patients take through healthcare systems using graph structures, enabling insights into patient experiences, care patterns...
NLP Processing for Unstructured Clinical Notes NLP processing for unstructured clinical notes involves using natural language processing techniques to extract, analyze, and interpret valuable information from free-text medical records, enabling improved clinical...
RWE/HEOR Data Management A process that includes acquiring, validating, storing, protecting, and processing required data to ensure the accessibility, reliability, and timeliness of the data.
RWE/HEOR Data Science and Modeling A process that helps make sense of your clinical data
RWE/HEOR Drug Response Analysis A process to understand how a population is responding to a drug, specifically if there are any adverse events.
RWE/HEOR Drug/Therapy Discontinuation Analysis An analysis to understand patient behavior. Are the drugs taken on time, do the patients discontinue use, and if so how long after starting, etc.
RWE/HEOR Machine Learning/AI Complex analytical approaches to find patterns and make predictions in RWE/HEOR projects
RWE/HEOR Market Analysis A process to understand how a drug is performing in the market and possible opportunities in the market
RWE/HEOR Software Tools Software designed to serve the needs of RWE/HEOR research groups.

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

Burden of Illness/Disease Strategy and study related to assessing the impact (economic, non-economic) of disease on health outcomes in a country, region, community, patient, or health system.
Comparative Effectiveness The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.
Cost Benefit Analysis Economic evaluation in which costs and benefits (outcomes) are expressed in monetary units, to determine if the benefits of an intervention outweigh the costs.
Cost Effectiveness Analysis Compare alternative treatments that lead to similar health outcomes.
Decision Analytic Modeling Assess effects, costs and economic outcomes of treatment. These include cost-effectiveness models and budget impact models.
Health Economics and Outcomes Research (HEOR) Evaluate data collected during drug development to maximize the value of a therapeutic product.

Show all 12 in HEOR 6 more

HEOR Adherence Studies Strategy or study that assess extent to which patients or subjects follow recommendations for prescribed intervention; may include compliance assessment, as well as reasons related to actual or potential non-adherence.
Patient Reported Outcomes (PRO) Assessment of health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician.
Patient Treatment Patterns Assessment of treatment processes and patterns within clinical practice.
Resource Utilization Descriptive and/or analytical review of a treatment that investigate the marketing, distribution, prescription, and use of drugs in populations. Endpoints to be assessed are the medical, social, and economic outcomes.
Systematic Literature Review Summarizes the results of research (that meet pre-defined eligibility criteria for inclusion) and provides a high level of evidence on the outcomes assessed.
Therapy Switch Insight into the reasoning of patients switching treatments and the outcomes of the switch.

Management Optimization & Development Strategies

Big Data Computational assistance with analysis of large data sets to reveal patterns, trends and associations

Market Access

Academy of Managed Care Pharmacy (AMCP) Dossier Summary document that presents clinical, economic, and humanistic value of an intervention and associated disease state with the supporting evidence, formulated from the perspective of a particular stakeholder...
Budget Impact Models A budget impact model (BIM) is a health economic tool used by decision-makers (such as hospitals, health boards, and payers) to estimate the financial consequences of adopting a new healthcare intervention, like a new...
Communication & Advertisement Distribution of a range of materials, through various communication channels, to highlight a message containing scientific-related topics
Emerging Market Opportunities Analyze risks and opportunities in new markets and ensure patients have timely and continued access to new treatments.
Environmental Analysis Research or strategy related to understanding the market (size, competition, reimbursement, challenges, etc.) and is a tool used to understand if a product can be launched in the market.
Formulary & Reimbursement Strategy Develop strategy and narrative to gain formulary access on insurance plans.

Show all 17 in Market Access 11 more

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.
Health Technology Assessment Submission (HTA Submission) Analyze the medical, social, ethical, humanistic, and economic considerations of a drug, medical device, or clinical procedures. Submissions are sent to regulatory agencies with different requirements that govern...
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.
Marketing and Commercialization Identify, promote and prove the value of a particular drug to key stakeholders.
Payer Toolkit Communicate product value to payers utilizing digital and mobile technology (For example, Payer-Facing iPad Models).
Population Health Analytics Aggregation of patient data across multiple health information technology resources, the analysis of that data into a single, actionable patient record, and the actions through which care providers can improve both...
Pricing Strategy Develop value story tailored to a payer audience that will determine the appropriate price for treatment.
Study Start Up Consulting Request for RWE/HEOR/Market Access Study Start Up Consulting
Value Based Agreements or Outcomes-Based Contracts Collaborate with payer or provider to develop a reimbursement plan outside of the traditional fixed cost-per-unit that ties reimbursement or price to actual health outcomes.
Value Dossiers Development Summary document that presents clinical, economic, and humanistic value of an intervention and associated disease state with the supporting evidence, formulated from the perspective of a particular stakeholder...

Medical Communications

Abstracts Request services related to the writing and review of abstracts
Communication Plan Communications plan enables organizations and corporations to effectively deliver information to appropriate stakeholders and customers.
Consensus reports Develop and submit a report that is a comprehensive examination by an expert panel of a scientific or medical issue.
Creation/Maintenance of Scientific Narrative and Lexicon Establishing and managing a unified set of core messages and terminology used across all company communications to ensure consistent scientific understanding.
Data Monitoring Committee (DMC) / Statistical Analysis Center (SAC) Find organizations in order to ensure patient safety and scientific integrity
Data Visualization Visualize data collected from clinical trials and/or clinical research.

Show all 57 in Medical Communications 51 more

Digital Opinion Leader (DOL) Mapping and Engagement Planning Systematic process to identify and compliantly plan engagement with influential digital experts (e.g., social media, online forums) within the medical and scientific community.
Disease or Drug-Related Literature Curation, development, and compliant distribution of written materials (e.g., abstracts, manuscripts, summaries) related to a specific illness or medicinal product.
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.
Gap Analysis Compare the actual performance of an organization or corporation with potential or desired performance, as ways to effectively analyze resource management or allocation.
HEOR/Value Publications Writing and submission of manuscripts and abstracts focusing on Health Economics and Outcomes Research (HEOR) data, which demonstrate the economic and value proposition of a therapy.
Internal Evidence Providing organized access and summaries of unpublished company-held data (e.g., clinical study reports) to internal medical and scientific teams.
Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) Dossier Develop and submit Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug (IND) Dossier
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.
KOL Engagement & Management Building and maintaining compliant, value-driven relationships with Key Opinion Leaders (KOLs) to collaborate on scientific exchange and clinical education initiatives.
Landscape Analysis Find a cohesive and consistent view of your main organization. Develop initiatives in analyzed areas of operations and analyze chosen key aspects of them.
Layperson Clinical Trial Result Dissemination Layperson clinical trial result dissemination involves translating complex clinical trial findings into clear, accessible language so that non-experts can easily understand the outcomes and implications.
Literature Audits A systematic review and assessment of all published and unpublished scientific literature related to a product or therapeutic area for compliance or strategic purposes.
Literature Monitoring Ongoing, systematic surveillance and analysis of published scientific literature to track emerging data, competitor activities, and changes in clinical understanding.
Manuscript Co-Authorship and Publications Planning Manuscript co-authorship and publications planning involve collaborating among researchers to write, organize, and strategize the submission and publication of scientific findings in academic journals, ensuring proper...
Market & Competitor Analyses Evaluating the current therapeutic landscape, identifying unmet needs, and assessing the scientific positioning and data of competitor products.
Mechanism of Disease (MOD) & Mechanism of Action (MOA) Videos Production of dynamic, scientifically accurate animated videos illustrating how a disease develops (MOD) and how a drug therapeutically affects the body (MOA).
Medical Affairs Services for non-promotional scientific exchange, supporting the dissemination of accurate medical data and the development of educational content.
Medical Affairs Dossiers Develop medical affairs dossiers such as Global Value Dossiers or AMCP Dossiers.
Medical Communications Request services related to the creation and development and medical communications content
Medical Communications Master Class Design and execution of in-depth, high-level educational sessions led by top Key Opinion Leaders (KOLs) focusing on advanced clinical or scientific topics.
Medical Information Encompasses both regulatory and non-regulatory medical writing. This function delivers balanced, evidence-based responses for reactive medical inquiries and develops strategic, proactive medical information platforms...
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.
Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
New Product/Indication Launch Planning Strategic development of the medical affairs communication road map and activities necessary to support the successful introduction of a new therapy or approved use.
Other Medical Affairs Videos Develop and design Medical Affair videos that are explainer videos and or augmented/virtual reality experiences.
Patient Advocacy Group Engagement Compliant collaboration and information sharing with non-profit organizations that represent patient communities to understand their needs and provide education.
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.
Payer Directed Communication Tools (other than Dossiers) Request services related to payer directed communication tools.
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.
Press Materials Associated with Key Publications Development of compliant communications such as press releases or media alerts for journalists and stakeholders, summarizing the data published in a major scientific journal.
Proactive and Reactive Medical Affairs Assets Development of both planned educational materials and responsive documents used by Medical Affairs to address scientific information gaps.
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.
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 Webinar Slide Decks Develop slide decks for sales training webinars.
Scientific Platform Develop a rigorous approach to creating a core story (grounded in the scientific literature) for a product. This involves identifying core concepts that address disease states, clinical needs, and product-related...
Scientific Positioning Strategic development of the evidence-based argument that defines how a drug or therapy is distinct, superior, or beneficial relative to competitors in the market.
Scientific Share of Voice Measurement Quantitative analysis tracking the volume and nature of a company's, or a competitor's, scientific discussion across publications and medical meetings.
Scientific Training Solutions Developing comprehensive educational programs and materials to ensure internal teams, field medical staff, or external partners are fluent in the therapeutic area and product data.
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.
Survey to KEE’s, External Expert Mapping Conducting compliant research and analysis to identify, categorize, and gather feedback from influential external medical and scientific experts.
Target Product Profile (TPP) A sponsor prepared document which summarizes the drug development program that is described in terms of the labelling concepts. This profile is a communication method used between the FDA and sponsor which can be used...
Therapy Area Disease Insights Report Creation of a comprehensive analysis of the current scientific, clinical, and competitive landscape within a specific therapeutic area.

Medical/Commercial

Health & Pharmacoeconomics Identify, measure and compare the cost-benefit ratio of products and services.
Life Cycle Assessment (LCA) Analyze the lifecycles of the products and services with regard to their environmental impacts.

Old Category HEOR, RWE, Market Access

Data - Other Extract insights and patterns from large and complex datasets.
RWE/HEOR/Market Access Disease/Clinical Outcomes Study the course of disease and the possible outcome of disease, including expected frequency.
RWE/HEOR/Market Access Hybrid Study Combine different methodologies (retrospective, prospective, registries, chart or claims review, electronic medical/health records) to gain insights into real world patient behavior or drug use.

Oncology Models

Oncology Models Use model organisms to test the therapeutic efficacy of cancer drug candidates.

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.
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.
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...
Risk-Based Monitoring Planning and Implementation Risk-based monitoring planning and implementation involve creating and executing a strategy that prioritizes monitoring resources based on the potential risks to patient safety and data quality in clinical trials...
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...

Show all 7 in Pharmacovigilance 1 more

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...

Primary Market Research

Advanced Analytics (Regression, Clustering, Factor Analysis) Applies complex statistical techniques to uncover hidden relationships and drivers. Generates predictive insights to inform decision-making and optimization.
Data Cleaning and Statistical Modeling Prepares raw datasets for analysis through validation, normalization, and advanced modeling. Ensures accuracy and enables robust, reproducible insight generation.
Journey Mapping (Patient, HCP, Payer) Visual representation of stakeholder experiences across disease or treatment timelines. Identifies pain points, decision triggers, and opportunities for engagement or support.
Payer and HTA Expectations Research Engages payers and HTA bodies to uncover evidence needs, pricing thresholds, and access drivers. Informs clinical and economic evidence generation planning.
Persona Development Synthesizes qualitative and quantitative data to build detailed, actionable profiles of stakeholder archetypes. Supports targeted communications and segmentation strategies.
Positioning and Value Proposition Testing Tests various positioning statements and value messages with target audiences. Refines messaging to maximize resonance and differentiation.

Show all 10 in Primary Market Research 4 more

Product Landscape and Unmet Needs Reports Synthesizes secondary data and expert input into landscape maps and gap analyses. Informs asset development and positioning.
Segmentation and Profiling Divides target audiences into distinct groups based on attitudes, behaviours, or demographics. Informs tailored messaging and targeting strategies.
Target Product Profile (TPP) Testing Tests stakeholder reactions to hypothetical product profiles across key attributes. Guides clinical development prioritization and access positioning.
Thematic Analysis Qualitative coding of transcripts or notes to identify recurring themes, patterns, and insights. Produces structured findings used to develop narratives and recommendations.

Public Affairs

Internal Communications Newsletters describing the process and updates related to the clinical trial.

Real World Evidence & Data

Claims Data & Database Analysis Analysis of care cost and quality.
Cohort Study Investigating the causes of disease to establish links between risk factors and health outcomes.
Data Merging Tools for combining various data sets into a single data set. Includes data consolidation.
Meta-Analysis Use quantitative statistical approaches to pool results across multiple studies to improve power or resolve uncertainty; may be used in conjunction with a systematic review.
Multi-Source Data Pools Multiple data sources aggregated into singular platforms for analysis. May or may not include real-time analytics capabilities.
Non-Comparative Study Assess an intervention using a single arm study design (without a control or comparator group).

Show all 23 in Real World Evidence & Data 17 more

Patient Reported Outcomes (PRO) Databases Database or collection of data related to health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician or anyone else.
Payer Outcomes-Based Contract Trial Study or analysis of data (claims, electronic HR/MR) to assess reimbursement or price to actual health outcomes.
Predictive Analytics Variety of statistical techniques from data mining, predictive modeling, and machine learning, that analyze current and historical facts to make predictions about future or otherwise unknown events.
Quantitative or Qualitative Research Either to understand concepts, thoughts, or experiences with qualitative research or to quantify the problem by generating numerical data or data that can be transformed into usable statistics with quantitative research.
Real World Evidence (RWE) Studies Studies (prospective or retrospective) utilizing data obtained from "real world settings" , and is outside the tight controls of a clinical trial design.
Real-World Data Acquire real-world data from patients' electronic medical records including clinical information generated during the course of healthcare.
Real-World Evidence Acquire clinical data from patients' medical records to analyze trends and the frequency of occurrence of different medical conditions.
RWD - COVID-19 Data from COVID-19 patients, can include diagnosis, treatment, among others.
RWD - Diagnostics/Laboratory Includes information on laboratory procedures/results.
RWD - Electronic Medical Record (EMR) Digital version of a patient's medical or health chart containing demographic, clinical, medical, and other treatment information.
RWD - Genomics Genomic data collected from a patients with different diseases, can be derived from a range of sources.
RWD - Oncology Data from oncology patients, can include clinical treatment, diagnosis, among others.
RWD - Rare Diseases Data from patients with rare diseases, can include clinical treatment, diagnosis, among others.
RWD - Wearables Data gathered from sources including pedometers, mobile devices, smart watches, among others.
RWE/HEOR Data Analysis Analysis that helps you make sense of your RWE/HEOR data
RWE/HEOR/Market Access Safety Surveillance Monitor safety of treatment and determine methods to identify adverse events early
Secondary Real World Evidence Analyze clinical trial data.

Regulatory Affairs

AMP Dossier Clinical Trial Dossier and/or United States Market Access Dossier
FDA Adcomm An FDA AdComm (Advisory Committee) is an independent panel of scientific, medical, and patient experts that evaluates the safety, efficacy, and clinical benefits of new medicines or medical devices.
Life Cycle Management Plan and strategy of the data collection and information throughout the different phases of product development (portfolio assessment, pre-clinical trials, clinical trials, pre-authorization, post-authorization, and RWE)
Periodic Safety Update Report (PSUR) 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
Post Launch EMA Consulting Post-launch European Medicines Agency (EMA) consulting assists pharmaceutical and biotech companies with the ongoing, post-authorisation phase of drug lifecycles.
Post Launch FDA Consulting Post-Launch FDA consulting refers to specialized regulatory services that help companies maintain compliance and monitor product safety after a drug or medical device is approved for the U.S. market

Show all 13 in Regulatory Affairs 7 more

Preparation Of Regulatory Dossiers Preparation of regulatory dossiers is the process of compiling detailed administrative, clinical, and scientific data into a standardized format
Regulatory Licence Updates A Regulatory Licence Update is a formal notification that communicates changes to the rules, conditions, or statutory requirements governing a licensed business or professional activity.
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.
Risk Benefit Assessment Determine ratio of treatment risk to the potential benefits.
Risk Evaluation & Mitigation Strategy (REMS) Evidence required by FDA to support the benefit of treatment outweighs the risks. Purpose of REMS is to prevent, monitor, and manage serious risk by informing, educating, and reinforcing actions to reduce frequency...
Safety Signals Early indication that a new or unknown adverse event occurred that may be caused by treatment and investigation is needed to determine a causal relationship. Can be investigated through spontaneous reports, studies...
Strategic Regulatory Advice Strategic Regulatory Advice involves expert guidance that helps businesses navigate complex legal and industry standards to achieve market access and maintain compliance. It serves as a blueprint for aligning business...

Regulatory Consulting

Toxicology Data Review Identify relevant toxicological endpoints for “No Observed (Adverse) Effect Level” (NO(A)EL) or “Lowest Observed (Adverse) Effect Level” (LO(A)EL).

Scientific Data Services

Bayesian Statistics Extract information from data sets that are subject to error or noise to see unobserved possibilities.
Data and Text Mining Derive structured data from free text in order to become accessible for data-mining algorithms.
Data Curation Organize and integrate data collected from various sources to ease data discovery and retrieval.
Data Lineage & Quality Track the various processes through which data has been created, edited or exchanged.
Data Quality Framework Manage data quality issues to maintain good quality data outputs.
Foundation Model A foundation model is a large-scale AI model trained on extensive datasets, designed to be adaptable for a variety of specific tasks.

Show all 12 in Scientific Data Services 6 more

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.
Machine Learning/ AI Predict and model an outcome (e.g. disease progression) based on input variables (i.e. features.)
Ontology Mapping Assign given ontologies to source data. 
Scientific Data Visualization Exploration and reporting of data by means of graphs and plots.
Software Tools Software tool for statistical analysis, data mining, genome annotation or NGS data analysis.
System Development Plan, create and deploy an information system.

Other services

Plain Language Summaries Request services related to the creation of plain language summaries.
Trial Awareness Create awareness about a clinical trial.

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