OUR SERVICES
Clinical Trial Operations
Oscentio provides clinical trial management services, from start-up through reporting, for Phase I through Phase IV trials. Our clinical trial operational services include clinical trial management, trial monitoring, site assessment and selection, site monitoring and maintenance, trial study start-up, trial subject recruitment, study feasibility, supplies management project management and bioavailability and bioequivalence studies.
Data Management
The success of any drug product development mainly relies on relevant and accurate data. We have personnel who are well-versed with cGCDMP, ICH-GCP, HIPPA, and 21 CFR Part 11 compliance.
Oscentio's end-to-end clinical data management services include pCRF and eCRF development, review, tracking and processing; clinical trial medical term coding (MedDRA, WHO-DD, ICD-9, and Client Dictionaries); data collection, storage, protection, retention, analysis, sharing, and reporting; electronic data integration and transfer; SAE reconciliation; clinical database lock; SAS XPORT transport files; on-site and off-site clinical data management services; clinical database design, development, and setup; data entry, review, analysis, migration, loading, and validation; database transfers; SAS datasets; and EDC helpdesk support 24/7.
Data Analysis
Oscentio's statisticians and statistical programmers have experience in a variety of therapeutic areas and regulatory standards including cGCDMP, 21 CFR Part 11, CDISC/CDASH, SDTM, ADaM, HIPPA, and global regulatory guidelines.
Services offered by our biostatisticians including clinical trial study design, study sample size calculations and randomization, statistical inputs to clinical study protocol development, statistical analysis plan (SAP) development and interpretation, and
statistical reports.
Services offered by our statistical programmers include SAS programming and implementation via CDISC (SDTM/ADaM) standards; generation of tables, listings, graphs (TLGs) and validation; performance of interim statistical analysis; clinical statistical and study reports writing; program validation; summaries of safety and efficacy for regulatory submissions; data derivation and mapping to CDISC standards; stand-alone statistical reports; and integration of databases across protocols.
Medical Writing
Oscentio's medical and scientific writers work on a variety of projects, including initial protocol development, clinical study reports, and regulatory documentation. Our writing services can be divided into 4 categories:
(1) Clinical Documents: Clinical study protocols and SOPs, case report forms (CRFs), investigator brochures, interim and final clinical study reports (Phase I-IV), consent and patient information forms, Clinical safety narratives, and integrated summaries
of safety and efficacy.
(2) Regulatory Documents: National and international investigational product submissions, including INDs, IDEs, NDAs, BLAs, ANDAs, MAAs, PMAs, and DMFs; orphan drug application support; drug and drug product annual reports; responses and briefing documents for regulatory agencies; Clinical sections of the Common Technical Document (CTD/eCTD); and risk management plans (RMPs).
(3) Pharmacovigilance Documents: Adverse events (AEs) and serious adverse events (SAEs) Narratives, periodic safety update reports (PSURs), and annual safety reports.
(4) Other Scientific Communications: Abstracts, manuscript, posters, brochures and slides; regulatory guidance; review of marketing materials; literature reviews; editorial support; journal and conference submissions; medical educational materials; and training materials.
Pharmacovigilance
Subject safety is the highest priority in clinical trials. We adhere to the strictest safety standards. Oscentio's pharmacovigilance services can be classified into six categories:
(1) Individual Case Management: Data entry and triage, case coding, narrative writing, quality control, and reporting.
(2) Aggregate Safety Reports: Periodic safety update reports (PSURs), benefit-risk evaluation reports (PBRERs), periodic adverse drug experience reports (PADERs), investigational new drug (IND) annual report, and developmental safety update report (DSURs).
(3) Risk management plan: Risk management planning and development, development and assessment of risk minimization, and risk management studies.
(4) Signal Detection: Signal detection and prioritization, statistical analysis in large, adverse Event databases, active surveillance, and signal assessment using pharmacovigilance database.
(5) Medical Call Center: Adverse events, product complaints, medical information, and 24 X 7 safety coverage.
(6) Other: Literature search and medical information, QPPV Support, inspection and audit support, physical retrieval of damaged products and analysis, PV Consultancy, and PV training.
Quality Control & Assurance
Oscentio attends to the highest quality control and quality assurance standards. These include Good Clinical Practices (GCP), Good Laboratory Practices (GLP), 21 CFR Part 11, ISO 9001, ISO 27001, ISMS certifications, and other standards of the FDA, EMA, and ICH. Our services can be classified into four categories:
(1) Auditing Services (Internal and External): Investigator sites, clinical trial facilities, central clinical and analytical laboratory sites, drug packaging and distribution sites, supplier / vendor / service providers sites, and Institutional Review Boards (IRB).
(2) Clinical Study Deliverables: Study protocols, Informed Consent Form audits, Trial Master File audits, Clinical Database audits, and Clinical Study Report audits.
(3) Validation Support: Computer systems validation, Clinical database validation, clinical trial management system validation, and process validation.
(4) Regulatory Agency Inspection Support: Support and training for FDA, MHRA, and other agencies inspection preparation (pre-agency audit).
Regulatory Affairs
Oscentio provides seamless, transparent, and current good regulatory consulting services to clients across pharmaceutical, biotechnology, API manufacturing, finished formulations manufacturing, medical device development, and food and beverage processes. Our team members are available to ensure successful product registration in the U.S., Europe, and other global market
places.
Oscentio's regulatory services include: CMC, Dossiers, strategy and intelligence from molecule to market; regulatory submissions (IND, NDA, ANDA, BLA and CTA applications [Paper & eCTD]); regulatory Writing (Clinical and CMC); regulatory labelling (Clinical and Non-Clinical); regulatory agency liaising; clinical and non-clinical publishing and submissions; as well as regulatory business and outsourcing consultancy.
Intellectual Property Rights
Oscentio's patent attorneys specialize in healthcare and life sciences intellectual property rights. We offer diverse services related to medical devices, active pharmaceutical ingredients (API), pharmaceutical products, and biotech drug products in generic and new discovery research. Our services can be classified into three categories:
(1) Patent Search Services: Search and analysis of patents, identifying design around patterns, patentability and invalidity studies, search reports, and clearance provision.
(2) Patent Filing Services: Patent drafting; filing patent applications; filing PCT applications; strategy and filing of applications in different Countries through professional partners; examination and prosecution services; preparing and filing
oppositions; patent maintenance; opinions on Orange Book; ANDA certifications; and notice letters.
(3) Portfolio and Innovation Management Services: Active Pharmaceutical Ingredients (APIs); formulations / drug products / dosage forms; biotechnology products; generic product selection; finished dose forms; medical devices; Para IV / niche product opportunities; establishing systems for organizations to manage IP; project management for developing products; IP due diligence; new indications identification for existing products; new dosage forms identification for existing products; and building and managing IP portfolios.
