Biostatistics

  • Biostatistics
  • Clinical Data Management
  • Statistical Programming
  • Quality Assurance

Biostatistics

Biostatistics is a specialized branch of statistics dedicated to applying statistical methodologies to biological and health-related data. It plays a vital role in designing, analyzing, and interpreting experiments and observational studies within the fields of medicine and life sciences. The primary goal of biostatistics is to extract valuable insights from complex datasets, supporting informed decision-making in clinical research, healthcare, and public health initiatives.

We Offer

Study Design & Protocol Development: Structuring research studies to ensure validity and reliability.
Statistical Analysis Plan Creation: Defining methodologies for analyzing collected data.
Randomization Schedule Development: Implementing randomized study procedures for unbiased results.
Protocol & Report Review: Examining case report forms (CRFs), clinical study reports (CSRs), and electronic CRFs (eCRF) for accuracy and compliance.
DSMB & Interim Analysis Planning: Coordinating Data Safety Monitoring Board (DSMB) evaluations and interim statistical assessments.
Integrated Summaries (ISS/ISE) for Regulatory Submissions: Compiling Integrated Summaries of Safety (ISS) and Efficacy (ISE) for regulatory compliance.
Publication & Ad Hoc Analysis Support: Assisting with research publications and tailored statistical analyses.
Statistical Consulting: Providing expert guidance on data interpretation and methodological decisions.
Clinical Study Report Data Management: Generating statistical tables, data listings, and figures for comprehensive CSR documentation.
Data Monitoring Committee (DMC) Services: Overseeing statistical integrity and monitoring study progress.

Clinical Data Management

Clinical Data Management (CDM) is an essential aspect of clinical research, dedicated to ensuring the accuracy, integrity, and security of data collected during clinical trials. Its primary objective is to systematically organize and process large volumes of trial data, enabling meaningful analysis for regulatory approval and scientific validation.

At its core, CDM involves data collection, cleaning, and management in a structured and standardized manner. By implementing rigorous validation protocols, it guarantees data quality, integrity, and compliance with industry regulations, facilitating reliable outcomes that support informed decision-making in drug development and healthcare advancements.
Let me know if you’d like refinements or additional details!

We Offer

Quality Assurance

The Quality Assurance plays a fundamental role in maintaining the integrity and reliability of processes, especially in validation and verification support. This role functions as a safeguard against errors, inconsistencies, and non-compliance, ensuring high standards are upheld throughout the project lifecycle. By providing meticulous oversight, the Quality Assurance strengthens operational efficiency and regulatory alignment.

In validation support, the focus is on ensuring that systems, processes, or products meet predefined criteria and adhere to regulatory requirements. This involves a rigorous review of documentation, procedures, and outcomes to confirm compliance with validation protocols. Additionally, validation support facilitates collaboration with project teams to establish validation plans, execute protocols, and assess process adherence, identifying and resolving deviations that could impact quality.

Verification support centers on confirming that systems meet specified requirements and align with industry standards. This entails an in-depth analysis of design documents, code, and test results to verify each component’s accuracy and functionality. The Quality Assurance works alongside development and testing teams to define verification criteria, conduct regular assessments, and implement effective verification procedures, minimizing the risk of defects and enhancing reliability.

By continuously monitoring validation and verification processes, the Quality Assurance plays a critical role in risk mitigation. Early identification of discrepancies prevents issues from escalating, ensuring that projects meet regulatory and operational expectations. This proactive approach not only enhances compliance but also contributes to the long-term success of the final deliverables.

Serving as a guardian of quality, this role fosters collaboration and structured oversight, helping organizations achieve operational excellence. Through rigorous review, meticulous assessment, and seamless integration of validation and verification practices, the Quality Assurance ensures that project outcomes are robust, compliant, and aligned with industry standards.

Our Services

Advanced Statistical Programming with SAS and R
Clinical Data Structuring & Standardization (CDASH, SDTM & ADaM – Mapping & Implementation)
Preparation of Regulatory Submission Packages (aCRF, Define.pdf, Define.xml & Patient Profiles)
Creation of Statistical Tables, Listings & Graphical Representations (TLFs)
Development & Validation of Analytical and Derived Datasets
On-Demand & Interim Statistical Analysis Support
In-Depth Review & Verification of Statistical Analysis
Pharmacokinetic (PK) & Pharmacodynamic (PD) Modeling and Data Evaluation
Compilation of Clinical Study Reports (CSR), Integrated Safety & Efficacy Summaries (ISS/ISE), and Annual Submissions
Optimization of Workflow through Custom SAS Macro Development

Statistical Programming

Statistical Programming leverages tools like SAS and R to process, analyze, and report clinical data with precision. It plays a critical role in ensuring data standardization, structuring, and compliance with regulatory requirements. Key aspects include data mapping, submission package preparation, and development of statistical tables, listings, and figures (TLFs) to present study findings effectively.

Additionally, advanced modeling techniques such as pharmacokinetic (PK) and pharmacodynamic (PD) evaluations support drug development decisions. By automating workflows with SAS macros and conducting interim and ad hoc analyses, statistical programming enhances efficiency and reliability, helping researchers generate meaningful insights for clinical trials and regulatory submissions.

We offer

Advanced Statistical Programming with SAS and R
Clinical Data Structuring & Standardization (CDASH, SDTM & ADaM – Mapping & Implementation)
Preparation of Regulatory Submission Packages (aCRF, Define.pdf, Define.xml & Patient Profiles)
Creation of Statistical Tables, Listings & Graphical Representations (TLFs)
Development & Validation of Analytical and Derived Datasets
On-Demand & Interim Statistical Analysis Support
In-Depth Review & Verification of Statistical Analysis
Pharmacokinetic (PK) & Pharmacodynamic (PD) Modeling and Data Evaluation
Compilation of Clinical Study Reports (CSR), Integrated Safety & Efficacy Summaries (ISS/ISE), and Annual Submissions
Optimization of Workflow through Custom SAS Macro Development

Our Service Models

Functional Service Provider
Full-Service Outsourcing
Talent As a Service
Hybrid As a Service

Let’s Connect

contact@panakeia.in
panakeiaclinicalservices
  • Biostatistics
  • Clinical Data Management
  • Statistical Programming
  • Quality Assurance

Biostatistics

Biostatistics is a specialized branch of statistics dedicated to applying statistical methodologies to biological and health-related data. It plays a vital role in designing, analyzing, and interpreting experiments and observational studies within the fields of medicine and life sciences. The primary goal of biostatistics is to extract valuable insights from complex datasets, supporting informed decision-making in clinical research, healthcare, and public health initiatives.

We Offer

Study Design & Protocol Development: Structuring research studies to ensure validity and reliability.
Statistical Analysis Plan Creation: Defining methodologies for analyzing collected data.
Randomization Schedule Development: Implementing randomized study procedures for unbiased results.
Protocol & Report Review: Examining case report forms (CRFs), clinical study reports (CSRs), and electronic CRFs (eCRF) for accuracy and compliance.
DSMB & Interim Analysis Planning: Coordinating Data Safety Monitoring Board (DSMB) evaluations and interim statistical assessments.
Integrated Summaries (ISS/ISE) for Regulatory Submissions: Compiling Integrated Summaries of Safety (ISS) and Efficacy (ISE) for regulatory compliance.
Publication & Ad Hoc Analysis Support: Assisting with research publications and tailored statistical analyses.
Statistical Consulting: Providing expert guidance on data interpretation and methodological decisions.
Clinical Study Report Data Management: Generating statistical tables, data listings, and figures for comprehensive CSR documentation.
Data Monitoring Committee (DMC) Services: Overseeing statistical integrity and monitoring study progress.

Clinical Data Management

Clinical Data Management (CDM) is an essential aspect of clinical research, dedicated to ensuring the accuracy, integrity, and security of data collected during clinical trials. Its primary objective is to systematically organize and process large volumes of trial data, enabling meaningful analysis for regulatory approval and scientific validation.

At its core, CDM involves data collection, cleaning, and management in a structured and standardized manner. By implementing rigorous validation protocols, it guarantees data quality, integrity, and compliance with industry regulations, facilitating reliable outcomes that support informed decision-making in drug development and healthcare advancements.
Let me know if you’d like refinements or additional details!

We Offer

Quality Assurance

The Quality Assurance plays a fundamental role in maintaining the integrity and reliability of processes, especially in validation and verification support. This role functions as a safeguard against errors, inconsistencies, and non-compliance, ensuring high standards are upheld throughout the project lifecycle. By providing meticulous oversight, the Quality Assurance strengthens operational efficiency and regulatory alignment.

In validation support, the focus is on ensuring that systems, processes, or products meet predefined criteria and adhere to regulatory requirements. This involves a rigorous review of documentation, procedures, and outcomes to confirm compliance with validation protocols. Additionally, validation support facilitates collaboration with project teams to establish validation plans, execute protocols, and assess process adherence, identifying and resolving deviations that could impact quality.

Verification support centers on confirming that systems meet specified requirements and align with industry standards. This entails an in-depth analysis of design documents, code, and test results to verify each component’s accuracy and functionality. The Quality Assurance works alongside development and testing teams to define verification criteria, conduct regular assessments, and implement effective verification procedures, minimizing the risk of defects and enhancing reliability.

By continuously monitoring validation and verification processes, the Quality Assurance plays a critical role in risk mitigation. Early identification of discrepancies prevents issues from escalating, ensuring that projects meet regulatory and operational expectations. This proactive approach not only enhances compliance but also contributes to the long-term success of the final deliverables.

Serving as a guardian of quality, this role fosters collaboration and structured oversight, helping organizations achieve operational excellence. Through rigorous review, meticulous assessment, and seamless integration of validation and verification practices, the Quality Assurance ensures that project outcomes are robust, compliant, and aligned with industry standards.

We Offer

Advanced Statistical Programming with SAS and R
Clinical Data Structuring & Standardization (CDASH, SDTM & ADaM – Mapping & Implementation)
Preparation of Regulatory Submission Packages (aCRF, Define.pdf, Define.xml & Patient Profiles)
Creation of Statistical Tables, Listings & Graphical Representations (TLFs)
Development & Validation of Analytical and Derived Datasets
On-Demand & Interim Statistical Analysis Support
In-Depth Review & Verification of Statistical Analysis
Pharmacokinetic (PK) & Pharmacodynamic (PD) Modeling and Data Evaluation
Compilation of Clinical Study Reports (CSR), Integrated Safety & Efficacy Summaries (ISS/ISE), and Annual Submissions
Optimization of Workflow through Custom SAS Macro Development

Statistical Programming

Statistical Programming leverages tools like SAS and R to process, analyze, and report clinical data with precision. It plays a critical role in ensuring data standardization, structuring, and compliance with regulatory requirements. Key aspects include data mapping, submission package preparation, and development of statistical tables, listings, and figures (TLFs) to present study findings effectively.

Additionally, advanced modeling techniques such as pharmacokinetic (PK) and pharmacodynamic (PD) evaluations support drug development decisions. By automating workflows with SAS macros and conducting interim and ad hoc analyses, statistical programming enhances efficiency and reliability, helping researchers generate meaningful insights for clinical trials and regulatory submissions.

We Offer

Advanced Statistical Programming with SAS and R
Clinical Data Structuring & Standardization (CDASH, SDTM & ADaM – Mapping & Implementation)
Preparation of Regulatory Submission Packages (aCRF, Define.pdf, Define.xml & Patient Profiles)
Creation of Statistical Tables, Listings & Graphical Representations (TLFs)
Development & Validation of Analytical and Derived Datasets
On-Demand & Interim Statistical Analysis Support
In-Depth Review & Verification of Statistical Analysis
Pharmacokinetic (PK) & Pharmacodynamic (PD) Modeling and Data Evaluation
Compilation of Clinical Study Reports (CSR), Integrated Safety & Efficacy Summaries (ISS/ISE), and Annual Submissions
Optimization of Workflow through Custom SAS Macro Development

Our Service Models

Functional Service Provider
Full-Service Outsourcing
Talent As a Service
Hybrid As a Service

Let’s Connect

contact@panakeia.in
panakeiaclinicalservices