Linical

Linical is listed as a mid sized business research supplier in the Scientist.com network, with 23 sites in 17 countries.

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Sites 23

Countries 17

Type of company: Mid sized business

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 Trial Feasibility Request services related to Clinical Trial Design and feasibility.

Clinical Trials

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.
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.
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.

Show all 18 in Clinical Trials 12 more

Patient Recruitment Recruit and retain patients for clinical trials.
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 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.

Data Science/Bioinformatics

Biostatistical Design Use statistics to ensure appropriate pre-clinical and clinical study design.

Medical Communications

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.
Competitive Intelligence Develop a coordinated competitive intelligence program which contains a systematic collection and analysis of information from multiple sources about a specific business's industry.
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.
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.
Market & Competitor Analyses Evaluating the current therapeutic landscape, identifying unmet needs, and assessing the scientific positioning and data of competitor products.

Show all 17 in Medical Communications 11 more

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 Science Liaison (MSL) Support Support services for Medical Science Liaisons (MSL).
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.
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.
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.

Show all 55 services 39 more

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 Audits and Inspections Ensure companies meet their obligations to comply with pharmacovigilance guidelines and report adverse events. Some guidelines include: - having personnel, systems and facilities in place to meet their...

Show all 12 in Pharmacovigilance 6 more

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...
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...
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...

Real World Evidence & Data

RWE/HEOR/Market Access Safety Surveillance Monitor safety of treatment and determine methods to identify adverse events early

Regulatory Affairs

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.

Other services

IND Writing Receive assistance with materials for an IND application.
NDA Writing Receive assistance in the NDA application process.

Website: www.linical.com

United States Brooklyn, Oradell, San Diego, Stuart 4 sites
China Beijing, Shanghai 3 sites
Japan Osaka, Tokyo 2 sites
Australia Sydney 1 site
Czechia Prague 8 1 site

Showing 5 of 17 countries.

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