Effective Medical

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

Email me this page as a PDF

Search companies, drugs, suppliers and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.

Sites 1

Countries 1

Type of company: Small business

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.
IND Writing Consulting Consulting for an Investigational New Drug Application

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

Case Reviews Review medical cases from Clinical Trials.
Consensus reports Develop and submit a report that is a comprehensive examination by an expert panel of a scientific or medical issue.
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
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 Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.

Show all 12 in Medical Communications 6 more

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.
Pharmacodynamic/ Pharmacokinetic Reports Create Pharmacodynamic/ Pharmacokinetic reports to report to the appropriate regulatory bodies.
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.

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.
IND/CTA Authoring and Publishing Services IND/CTA authoring and publishing services involve preparing, compiling, and submitting Investigational New Drug (IND) applications or Clinical Trial Applications (CTA) to regulatory authorities, ensuring compliance...
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...
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...

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...

Show all 25 services 10 more

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.

Work with Effective Medical on Scientist.com

For prices, more details, or to contact Effective Medical, visit Scientist.com.