Profile Details

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USD 70 /hr

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Hire Rudra P.

India

USD 70 /hr

Group of Clinical Research Professionals (Project Manager, Biostatisticians, CRAs, Medical Writers, SAS Prgmers)

Profile Summary

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical analysis, staffing and training. Our preferred medical writing and bio-stat experts (Phd Pharmacology, MD Pharmacology, MS Clinical research, Phd in Biostatistics, PhD Pharmaceutics, PhD Pharmacognocy etc) team is having extensive experience and trained in pharmaceutical and CRO industry with sound information technology background. Our services and deliverable are in accordance with regulatory and industry standards. We provide various types of medical writing (scientific and regulatory) and statistics services. We have been preparing various required documents for our global clients. We are a group of Clinical Research Professional (Project Manager, Bio-statisticians, CRAs, Medical Writers, SAS Programmers) working to provide professional services. Our statistics services are as below: Clinical trial End-to-End Biostatical Services • Biostatistical Consultancy • Protocol/SAP development • Randomization plans • Database and TFL production • Datasets and TFL production to CDISC and non-CDISC standards BA/BE Study • Efficient, cost-saving study designs • Sample size calculations • Randomization services • Statistical analysis • Outlier detection • CDISC Data Conversion (ADaM and SDTM) • PK/PD analysis Pre-Clinical Studies • Support and advice for pre-clinical studies. Other study • Adhesion, Irritation stat analysis • Bootstrap stat analysis for dissolution data • Population bioequivalence (PBE) for Vitro study • ISS/ISE - Integration of safety and efficacy data prior to regulatory approval • Meta Analysis, Systemic Review, Umbrella Review, Meta Umbrella Review Regulatory Writing: Regulatory writing services include the development of various regulatory documents, including but not limited to: > Clinical Study Documents for all clinical trial phases and study designs -Clinical study protocol, study synopses and amendments -Investigator’s brochure including annual updates -informed consent documents -Case report forms -Other patient/study related materials like advertisements, patient cards, patient diaries, etc. -Prescribing information > Clinical Study reports (ICH-E3 compliant) > Marketing authorization applications for drug, device and biologics for all regulatory authorities including EMA, FDA, CDSCO, and emerging markets. -Clinical sections of CTD submissions (Modules 2.5, 2.7 and 5.0) and expert statements -Non-clinical sections of CTD submission (Modules 2.4, 2.6, and 4.0) and expert statements -Update and gap analysis of various CTD components > Medical Device Writing: - Clinical Evaluation Plan - Clinical Evaluation Report (CER, according to MEDDEV 2.7/1-Rev.4), - Biological Evaluation Plan and Report (BER, according to ISO 10993), - Risk Management Plan (according to ISO 14971), - Post-Market Clinical Follow-up Plan and Report (PMCF, according to MEDDEV 2.12-2); - Clinical Investigation Protocol (CIP, according to Good Clinical Practices ISO 14155, MDD 93/42/EEC, MDR 2017/745) and - Instruction for the Use of Class II and III Medical Devices according to Medical Device Regulations MDD 93/42/EEC and MDR 2017/745. > Patient safety narratives > DSMB updates, integrated safety summaries, risk management plans (EU-RMP), aggregate reports (DSURs, PSURs – compliant to ICH E2C and E2F guidance) and other pharmacovigilance documents > Regulatory meeting briefing documents, response to questions document > Statistical analysis plan in conjunction with biostatisticians > Feasibility survey reports, disease demographics > Standalone QC and review of documents Publication writing services include: > Publication planning > Primary and secondary manuscript writing > Manuscript editing and proof-reading > Handling journal submissions, revisions, rejections and acceptance > Literature Reviews > Case reports/series > Brief communications, letters to editors > Scientific Abstracts > Scientific Posters > Meta Analysis and Systematic Review (MA and SR) Educational medical writing services include: > Systematic literature search > Scientific presentations > Educational slide decks, training modules > Data presentations for medical conferences > Patient information leaflet > Physician information booklet > Study newsletters > Health articles for newspapers and magazines > Research grant writing > Sales literature for newly launched drugs, > Standard operating procedures (SOPs) Toxicology and Pre-Clinical Services: - ISO10993 - General Toxicity - Immunotoxicology - Inhalation Toxicity - Eco Toxicity - Reproduction & Development Toxicity - Biological Tests - Physico Chemical Testing, Chemical/Drug Characterization - Mutagenicity - DMPK

Subject Matter Expertise

• ★ Clinical Trials
• ★ Regulatory Writing
• ☆ Biostatistics
• ☆ Immunoassay
• ☆ Biomarkers
• ☆ Basic Immunology
• ☆ Database Management
• ☆ Manufacturing
• ☆ Data Analysis
• ☆ Data Management
• ☆ Statistics
• ☆ Meta-Analysis
• ☆ Regression Analysis
• ☆ Statistical Computing
• ☆ Health Data Analysis
• ☆ Bioinformatics
• ☆ Immunohistochemistry
• ☆ Historical Research
• ☆ SPSS
• ☆ SAS
• ☆ Drug Design
• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ Microbiology Testing
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Medicine
• ☆ Allergy & Clinical Immunology
• ☆ Immunogenetics
• ☆ Reproductive Medicine
• ☆ Healthcare
• ☆ Medical Toxicology
• ☆ Herbal Medicine
• ☆ Immunotherapy
• ☆ Medical Sciences
• ☆ Cancer Research
• ☆ Carcinogenesis
• ☆ Research Methodology
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Technical & Scientific Writing
• ☆ Manuscript & Journal Article Writing
• ☆ Systematic Literature Review
• ☆ Herbal Products
• ☆ Project Management
• ☆ Management Consulting

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting

Research Market Research, Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis, Algorithm Design-Non ML, Data Visualization

Product Development Formulation

Work Experience

Manager Operations

SymGet

March 2016 - Present

Project Manager

Confidential

December 2005 - February 2016

Education

MS

Masters in Clinical Research

May 2004 - June 2006

B- Pharmacy

North Maharastra University

January 2000 - January 2004

Certifications

• Certification details not provided.