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Quality is a key in every thing we do.  The function serves internal assurance as well as provides expert services to sponsors as requested. Our Quality Assurance services include audits, audit plans and audit reports. Proscizen QA performs various audits in the range of services we offer such as -

1. Investigator Site Audit
2. Protocol Audit
3. Informed Consent Audit

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4. CRF Audit
5. Database Audit
6. CSR Audit
7. Vendor Audits
8. TMF Audit
9. Sponsor or regulatory Audit

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10. Facility Audit

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11. Computer Validation Audit
12. System Audit

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 Our medical writing and scientific communication services includes  

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1. Support for regulatory documentation  
2. Writing Protocols and protocol amendments
3. Writing Synopses
4. CSR subject narratives

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5. Study safety narratives
6. Informed consent forms
7. Investigator brochures

Scientific Communication and Publication Writing services

1. Preparation of reports of interim and completed analysis, with an integrated approach with the regulatory division

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2. Primary and review manuscripts
3. Slide presentations
4. Abstracts
5. Posters
6. Assistance with Journal Submission, including comparative analysis of choice of journal
7. Ensuring incorporation of required editorial changes in submitted documents
8. Co-ordiantion with sponsors and authors
9. Others such as editorial support, content for CME etc

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We offer expertise in providing statistical analyses and descriptive summaries for clinical studies and work collaboratively with the sponsor to achieve the statistical integrity and objectives of the study.

Our biostatistics and programming services includes but not limited to

1. Statistical Inputs to Protocol

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2. Creation of Statistical Requirement Document,
3. Creation of Statistical Analysis Plan (SAP)
4. Sample Size Determination
5. Conduct of Statistical Analysis (Interim and Final),
6. Macros and TLG Programming
7. Data Integration and Mapping/ISS/ISE,
8. Randomization and unblinding of treatment codes
9. Statistical Report and other statistical documentation
10. Statistical support for Data Monitoring Committee Inputs

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Using validated and industry standards 21CFR compliant systems for paper and EDC trials, our CDM services includes

1. End to end clinical data management for paper and EDC studies
2. Creation of data management plan and Preparation of edit check documents

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3. e (CRF) design
4. Annotation of CRFs
5. Database design, testing and validation
6. Scanning and Indexing
7. Data entry and discrepancy management
8. Data Integration
9. Medical Coding
10. Automatic and manual medically supervised generation of DCFs
11. QC, Database lock and transfer
12. EDC validation and programming
13. Site assessment for EDC
14. Training and support/ Helpdesk
15. Tracking and reporting including customer reports

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Active Pharmacovigilance services is part of our  integrated clinical research offerings. We can provide support to sponsors across desired time zones. Our SOPs for pharmacovigilance operations are compliant to global regulatory and GPvP guidelines

Proscizen’s drug safety data management services includes but are not limited to -

1. Safety monitoring plan
2. Safety data base creation and configuration support
3. Safety database change and maintenance

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4. Case reception, encoding and reconciliation
5. Case narrative writing
6. Case assessment
7. Processing medical information request
8. Review of literature reports
9. Reportability analysis, compliance reporting and follow up
10. Submission support for expedited safety reports including SUSAR, Annual safety report, PSURs
11.  Investigator Alert Letters
12. EMEA Eudravigilance Registration and Testing
13. Analysis of Similar Events

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14. AE/SAE Reconciliation
15. Pregnancy reports
16. Post-Marketed Safety Surveillance:

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Our proficiencies include extensive development of rater training material (including training tapes), training in scales, and conduct of rater- reliability exercises. Rater has experience of conducting rater trainings across US, EU, Africa and APAC with training of (10-400) investigators from these regions in each meeting.  The exposure also includes provision of oversight in rater-training meetings across multiple linguistic groups in Europe and Asia.

Through extensive rater training capabilities, Proscizen works to improve the quality and consistency of test administration and test scoring/behavioral rating of scales so that data are more valid and reliable. Our key services in rater training are -

1. Preparation for rater training
2. Surveys of rater experience
3. Development of Rater Training manual
4. Conduct of rater training at investigator meetings
5. New Rater training, tracking and certification
6. Online rater training
7. Recalibration

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8. Central monitoring of raters
9. Ongoing support for rater training
10. Analysis and report of rater data from investigator meeting with follow-ups wherever necessaryProduction of video tapes

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11. Translation of scales and videotapes

Proscizen provides a comprehensive range of feasibility services for conducting a trial in India. Our approach and services for such feasibility assessment, includes but not limited to

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Proscizen’s medical monitoring expertise includes –

1. Creation of medical monitoring plan
2. Training of project team  and resolution of project specific procedural problems
3. Medical review and interpretation of clinical data and documents including but not limited to Protocol, CRFs, Informed consent forms, safety narratives, clinical study report
4. Medical interactions with Proscizen project team, sponsor, and site clinical staff
5. Medical review of data after data entry

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6. Medical review and reporting of safety-related events
7. Other medical activities on behalf of sponsor