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Research supplier
Clinexel Life Sciences Private Limited
Clinexel Life Sciences Private Limited is listed as a small business research supplier in the Scientist.com network, with 1 site in 1 country.
View Clinexel Life Sciences Private Limited on Scientist.com
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Sites
1
Countries
1
Services
What this research supplier says it provides, as listed in the Scientist.com network.
Type of company: Small business
Clinical Consulting
- Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.
- Study Budgeting Consulting Request for Consulting Services
Clinical Trials
- Case Report Monitoring & Auditing Ensure the adequate collection and traceability of clinical data in preparation for review by the FDA.
- Clinical Trial Risk Management Plan that maintains treatment quality throughout lifecycle and improve decision making.
- Site Monitoring Maintain oversight over participant's health during a clinical trial.
- Study/Site Feasibility Study Explore and test study practicality.
HEOR
- 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.
Medical Communications
- Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
Old Category HEOR, RWE, Market Access
- RWE/RWD Enriched Studies 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.
Real World Evidence & Data
- Exploratory Study Explore study design, outcomes, data-collection method, and selection of population for a topic that needs more research information.
- Pragmatic Clinical Trial Randomized trial comparing two or more treatments in a real world setting. The trial possesses minimal exclusion criteria and closely follows the procedures of the clinical practice in order to mirror clinical care...
- 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.
- Registries - Disease Database containing, through utilizing observational research methods, standardized data about patients who have the same disease.
- Registries - Patient Database containing, through utilizing observational research methods, standardized data about patients who have the same condition, disease, or exposure and is used to evaluate an outcome
- RWE/HEOR/Market Access Safety Surveillance Monitor safety of treatment and determine methods to identify adverse events early
Show all 7 in Real World Evidence & Data
- 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.
Show all 26 services
Regulatory Affairs
- 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)
- Medical Labeling Design and create medical labels that accurately reflect purpose, precautions and other information.
- Patient Risk Management Identify, contain, and manage risks related to patient safety.
- Period Benefit Risk Evaluation Report (PBRER) 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
- 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 Authorization Efficacy Study (PAES) Answer uncertainties in efficacy of treatment, and improve understanding of treatment and the benefit-risk profile. These studies are specifically asked for by European Medicines Agency (EMA) to continually grant...
Show all 9 in 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.
- Risk Benefit Assessment Determine ratio of treatment risk to the potential benefits.
- 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...
- Website
- www.clinexel.com
Where it operates
Sites by country, with the cities in each.
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India 1 site
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