Services

1) CLINICAL OPERATIONS

CLINZTECH having a strong project management team which is underpinned by comprehensive and consistent processes, which conform to global regulatory requirements from start-up to completion.

We have the highly experience and in depth knowledge to find, recruit, and retain patients in clinical trials. We successfully deliver access to appropriate sites and patients, developing strategies that will minimise the risks inherent in patient recruitment. The performance is monitored and measured against contractual timelines and project costs are tracked to ensure adherence to agreed budgets.

  • Clinical Study and Site management
  • Project Management - Clinical Research
  • Applying advanced models and predictive analytics
  • Study start to ending using streamlined processes and leading edge Information technology
  • Patient focused methodology for the design and execution for a monitoring strategy.
  • Site, Investigators, and Patient recruitment
2) MEDICAL WRITING

CLINZTECH has comprehensive understanding of various regulatory guidelines such as ICH-GCP, FDA, EMA guidelines. Our team consisting of persons with qualifications in medical, pharmaceutical and other life science subjects, speciality doctors who have expertise across all the therapeutic areas.

We also provide medical writing services in Japanese, German and French languages.

  • Skilled Areas:
  • Synopses
  • Protocols and amendments
  • Investigators Brochure
  • Informed Consent Forms(ICFs)
  • Clinical Study Reports
  • Clinical Summaries
  • Study Reference Manual
  • CTD modules
  • Annual and periodic Safety Reports
  • Non-clinical Study Reports, Summaries and Overviews
3) CLINICAL DATA MANAGEMENT:

CLINZTECH, Clinical Data Management (CDM) team helps clients maximize the data generated from clinical trial to improve efficiency, reduce overall development costs (Both Paper base and EDC system), and reduce the risk for subjects and themselves for studies ranging from small rare disease studies to large global ones.

Combining a global team with experienced clinical data managers and statistical programmers with innovative, proprietary technologies, our team provides high-quality data throughout the life cycle of a clinical study for periodic analysis, reporting and for regulatory submission, approvals.

  • Building several customized database as per Client requirements.
  • Successful transitioning of on-going project from Study Start-Up to Close-Out Phase
  • Operating in accordance with both Client's or CLINZTECH SOPs
  • A focus to minimize customer oversight
  • Supporting Metadata Repositories (MDR) and Statistical Computing Environments (SCE) transition and development of Data Standards
4) STATISTICAL ANALYSIS SYSTEM (SAS)/ BIOSTATISTICS:

CLINZTECH, SAS programming services provide scalable statistical support with expertise in the Clinical process. India is comprised of highly qualified SAS programmers dedicated to biopharmaceutical development projects.

CLINZTECH provides customers a wide range of solutions under one roof. We can handle either full life cycle end-to-end solutions or just a small part of a project, confidentiality protection, and several other protective measures.

Biostatistics Services:
CLINZTECH team designs project management solutions that guarantee reliable and timely achievement of milestones. Our focus is to ensure the integrity of your data and organize your findings and conclusions into a clear and results-oriented presentation.

Our biostatistics and statistical programming services include pre-analysis, analysis and post-analysis:

  • Developing protocols / Planning sample size
  • Establishing statistical analysis plans
  • Planning and implementing randomization
  • Preparing and analyzing ISE/ISS databases
  • Conducting data mining and exploratory analyses
  • SAS programming for interim and final analysis
  • Providing support for regulatory and advisory meetings

CLINZTECH statisticians, who are all well Qualified and are familiar with regulatory requirements and skilled in statistical methodologies. Our statistical programmers are versatile and experienced in the use of SAS, enabling us to generate QA report summaries and listings to meet your Client specifications.

5) PHARMACOVIGILANCE

CLINZTECH manage your Safety and Pharmacovigilance needs at any stage of product/device development to ensure quality and compliance:

  • Clinical trial safety: Phase I-IV, from data entry to case closure, full processing, including expedited/periodic reporting
  • Post-marketing safety: AE case processing, reporting, signal detection, U.S.-based call center, literature search and review, product complaints, EU QPPV and Litigation case processing
  • Safety regulatory submissions: Dedicated subject matter experts in safety regulatory legislation and submissions
  • Safety physicians: We have dedicated/trained physicians in all aspects of the life cycle of safety and Pharmacovigilance
  • Safety database: Dedicated support team with expertise in working both in customer and other databases as per client requirements.

Pharmacovigilance legislation has become more stringent than ever, dramatically changing the game for compliance. Reporting needs to be significantly more robust and specialized, and as a result customers are increasingly outsourcing safety and Pharmacovigilance services. We can provide:

  • Automated safety report distribution system with pre-programmed regulatory reporting requirements. Adaptable, secure and controlled delivery of expedited and periodic reports to regulatory authorities, ethics committees and investigator sites with full tracking and audit trail
  • A multi-tenant, fully validated, 21-CFR part 11 and E2B compliant safety database system, generating standard regulatory reports, with the flexibility to be customized to meet your specific requirements
  • Dedicated regulatory safety intelligence team with access to a regulatory intelligence database allows for continuous monitoring of regulatory requirements across the globe
  • Our safety and Pharmacovigilance teams support clinical trial and post-marketing safety surveillance across the globe. With patient safety as the critical component in product development, our quality focus aligns us to partner with our customers to provide both standalone and integrated services throughout the life cycle of a product.
6) QUALITY ASSURANCE:

In addition CLINZTECH will provide in-house Quality Assurance auditing for all Clinical trials, IT, Banking and Finance etc., the Quality Assurance department provides standalone services to support companies to develop, implement and maintain quality management systems to assure the highest standard of conformance to GCP, GMP and GLP regulations.

  • Our QA services encompass the following:
  • Auditing (In-house and from Third Parties/External)
  • Phase I - IV GCP audits
  • Clinical laboratories (GCP, GLP)
  • Database and Statistical tables
  • Computer validation
  • Clinical trial reports
  • Pre-FDA/regulatory inspections
  • Quality Systems Development (GCP, GLP)

With QA personnel located across Europe and the US, Asia-Pacific, Latin America and Japan the QA team is flexible enough to provide an individual and personalised service for locally managed projects.

7) MEDICAL CODING:

CLIZTECH offers complete medical coding solutions. Our team of highly trained, experienced and certified coders ensures that your coding is accurate, thereby maximizing your reimbursements while adhering to strict compliance and security guidelines.

  • Coding Services:
  • Extremely competitive pricing, with a fixed cost per report.
  • Extremely efficient process and coded reports are returned along with your transcriptions each day.
  • Ability to access coded reports any time, day or night.
  • Stay current with the latest coding requirements.
  • Audit your current coding process.

When combined with our Transcription Service, both transcribed and coded reports are received the following business morning, adding to your workflow efficiency. This also eliminates sending out the transcriptions for coding, managing missing reports, and keeping track of the process on separate systems and combined system makes it easy to manage your document process from dictation through to transcription and coding, efficiently and easily.