Our Services
Clnical Research
Clinical Trails (phase I to III)
ISAPS CRO offers comprehensive solutions for clinical trails across early-phase,pivotal, and post markting stages for global pharmaceutical and biotech sponcers. Our experienced team ensures high-quality and timely deliverables, adhering to industry best practices.
BA/BE
At ISAPS CRO, we specialize in bioavailability and bioequivalence studies leveraging our extensive expertise in this field.Our study dedicated monitors provide real-time onsite monitoring to ensure compliance ,accuracy and reliability.with our skilled QC coordinators and trustworthy study outcomes.
Pharmacovigilance and drug safety
At ISAPS CRO, we emphasize the importance of pharmacovigilence throughtout the drug lifecycle,prioritizing patient safety and quality.by adhering to good pharmacovigilence practice, we build confidence among HCPs and patients globality.our services are tailored to meet the specific regulatory needs of ensures continuoes monitering of key performance indicator to achive regulatory excellence.
Case Process
ISCR Case Processing: ISAPS CRO ensuring thorough processs of ICSRs ,adhering to global regulatory standards to guarantee the safety and efficacy of pharmaceutical products.
literature search:
ISAPS CRO conducted comprehensive literature searches to identity and evaluate and evaluate relevant safety information, ensuring compliance with regulatory requirements
Aggregate Reporting
We specialize in aggregate reporting, compiling safety data from various sources to provide comprehensive overview that meets to regulatory standards and supports risk assessment.
Signal Management
Our signal management services involve the identification and evaluation of safety signals, enabling proactive risk management and timely responses to potential safety concerns
Risk Management
We offer risk management solutions that assess and mitigates potential risks associated with drug safety, ensuring compliance with regulatory guidelines and potecting patient safety.
Qualified person for Pharmacovigilance(QPPV services)
Our QPPV services provide expert oversight and guidence in pharmacovigilance,ensuring,that your organization meets all regulatory obligations and maintains high safety standards.
Safety Data Exchange Agreements(SDEA) Management
Our SDEA management services facilitates the effective exchange of safety data between parties, ensuring compliance with legal and regulatory requirements.
Provision of Safety Database:
We provide robust safety database solutions that support the efficient management and reporting of safety data, enhancing your pharmacovigilance capabilities.
Safety Data Migration Assistance
Our team offers seamless migration of safety data, ensuring data integrity and continuity during transitions.
Data Sciences
Biostastics
- Each phase of the clinical trail process necessitates the expertise of biostatasticians. We enhance clinical trails by providing thorough and meticulous analysis.
- Ststical inputs to control
- Sample size and power estimation
- Randomization for open ledel and blinded studies
- Statical Analysing plan devolopment
- Statistical analysis for trail data
- support for DSMB/Interim Analysis/BDR activities
- Full DMC support, including preparation of the DMC charter
- PK and PD analysis
- Interpretation of results and input to clinical study reports
- Exploratory Analysis
Clinical Data Management:
- Database & eCRF Design, Edit Checks, programed Dynamics,& UAT
- EDC Platform Development: inform, medidata RAVE,Veeva vault,Medrio, & Open clinaca
- Programed standard & smart data listings
- Data quality, data cleaning, & Data Resoution
- SAE Reconciliation/External Data Reconciliation
- External vender & project team management
- Document creations including DVS,DMP Data entry guidelines
Medical Information
ISAPS CRO Medical information professionals undarstand the importance of providing balanced,accurates and timely responces to help our make informed decisions.wheter inquiries come from physian,patients, pharmacite or caregivers, our team is dedicated to providing the best possible support while adhering to strict regulatory standards, ensuring highest quality and daa security. From aversce intake and follow-up to contant management solutions,medical literature review, and other extended medical information services, our dedicated experts posses the knowledge and expertise to support you.
Medical Writing
ISAPS CRO excels in providing high-medical writing services, tailored to meet the specific needs our clients. Our team experienced medical writers and editers create comprehensive,accurate and compliant documents for clinical research and regulatory submissions from clinical study reports and regulatory dossiers our expert ensure clarity and precision in every document. By adharing to stringent regulatory standards and industry best practices, ISAPS CRO support your clinical devolopment programs with reliable and impactable medical writing solutions.
Quality Assurance
Our quality control and assurance facilities to integral to our commitment to excellance. we conduct regular audits and compliance checks to ensure that all processes meet industry standards and regulatory requirements.
GCP,QA and Audit support :
ISAPS CRO ensure adherence to good clinic practice through rigorous Quality assurance audit support.
GVP quality support:
ISAPS CRO maintains the highest standards of good pharmacovigilance practice to ensure drug safety.
QMC consulting:
Providing expert consultancy on Quality management to enhance operational efficiency and regulatory compliance.We provide tailored solutions that align with industry standards and best practices, ensuring that yuor processes are optimized for maximum effectiveness.
Specialty areas:
Our expertise spans a wide array of therapeutic areas, including but not limited to cordiology,oncology, Diabetes,Rheumatoid Arthritis,Opthomology, Dermatology,Pumary Diseass, Gastroenterology,Neuarology, infectious diseases, Endocrinology, and respiratory Diseases.
- Number of Hospitals/sites
- Number of principles Investigators
- Hospital bed streghth/capacity