Bio-pharmaceutics & Data Science Dept
Bio-pharmaceutics & Data Science Dept
Biopharmaceutics and data science department forms a centralized model that assimilates biostatistics, programming, and clinical data management services. At Veeda, we provide high quality services regardless of complexity with qualified and experienced statisticians, pharmacokineticists, SAS/clinical programmers and data scientists. We strive to deliver robust and unswerving analyses and reports while articulating them in an accessible manner. We are well equipped to provide comprehensive services with technical competencies & organized team structure. Our effective communication with sponsors and increased accountability within the team helps us in ensuring that projects stay on track, on time, and within budget.
Bio-pharmaceutics Services
Bio-pharmaceutics Services
Successful development of a new drug, generic medicines and biologic medicine count on ensuring the safety, efficacy, quality, purity and potency of any such product. To expand the product portfolio and achieve developmental milestones with greater compliance with regulatory requirements, you will need quality data to obtain hassle free approval and allow informed decision making for the development of quality drugs. With a profound knowledge of the latest regulatory requirements, we can help you meet the authorization requirements for major regulatory submission, providing regulatory compliant data for each project. Our scientists ensure that the data is compliant with Good Clinical Practice (GCP) and respective regulatory standards. Our laboratories conduct analytical programs to help you meet specifications and support your regulatory submissions;Investigational new drug application (IND) or new drug application (NDA) / ANDA (abbreviated new drug application) / biologics license application (BLA).
Statistical Services
Statistical Services
At Veeda Clinical Research, we provide wide range of biostatics services, wherein our team provides the highest level of scientific data with high quality and integrity. Veeda provides a robust list of services in the statistics starting from raw material stage to clinical and post marketing evaluations. Our statisticians have hands on experience in performing statistical analysis of clinical studies with different designs and different level data. We have a wide range of bio statistical services designed to support product development program which are enlisted below:
- Pharmacokinetic end point studies
- Pharmacodynamics end point studies
- Dose proportionality studies
- Food effect studies
- Clinical endpoint studies
- Design of Experiment (DoE)
- In-vitro population bioequivalence (PBE)
- In-vitro equilibrium binding and kinetic binding studies
- Simulations
Softwares/Tools used in statistics:
- Phoenix WinNonlin
- SAS
- R studio
Clinical Data Management (CDM) Services
Every customer and project is unique, requiring a customise approach to maintain the quality. To fulfil the costumer requirement our team combining the latest technologies with years of data management experience and adopts an intelligent approach to developing and implementing quality data collection solutions.
Our Clinical Data Management Services include:
- EDC and paper trial set-up & management
- Data management plan (DMP)
- CRF/eCRF design and development
- CRF annotation & review
- Database build & design
- Data validation plan
- Edit checks programming & testing
- Data processing through double data entry
- Query management
- Medical coding
- Safety data management & reconciliation
- External data handling
- Data export/Transfer
- CDASH compliant deliverables
- Real-time data viewing and reporting
Why Veeda?
- Veeda is an independent indian CRO with 16 years of experience
- Veeda has conducted over 3800+ studies & has worked with over 200 (Bio)pharmaceutical companies around the world
- Veeda has an exemplary regulatory record of successfully completing audits of USFDA, AGES, MHRA, ANVISA, WHO, NPA, ANSM, MCC, DCGI & NPRA
- Due to stringent quality norms and transparency at all stages, Veeda is considered to be a preferred partner for many (Bio)pharmaceutical companies
- Veeda’s has a vast experience in scientific and regulatory compliant protocol designing that enables the drug development process of Early to Late phase clinical trials
- Veeda has over 900+ analytical methods & 60+ NCE molecules developed and validated so far
- Veeda ensures study specific clinical safety measures for all volunteers through risk mitigation strategies
- Veeda has Quality Management System in place to capture any non-compliance or deviation identified during the study with an effective mechanism of corrective and preventive actions implemented
