Rescue Studies

RAPID ASSIST Rescue Services
Considering the diversity of our country and India's unique regulatory and demographic environment, Neeman Clinical Research can help you to achieve your vision with its mission of providing quality delivery of service to both external and internal customers. Fast Rescue Study Start-up
A new initiative of the Indian regulatory authority makes it possible to start your study in India within 6 weeks. This directive applies to any study that is currently approved and under way in the United States, the European Union, Japan, or another major country. Access to Thousands of Patients
With a population exceeding 1 billion people and a well developed healthcare infrastructure, India has plenty of patients in virtually all therapeutic areas and indications. In particular, India has a high prevalence of diabetes, cardiovascular disease, hepatitis, cancer, CNS indications, and infectious diseases. For most diseases the standard of care is inline with the Western countries, including the same diagnostic tools and drugs. Still, because of lower health awareness, many "treatment-naïve" patients can also be found in all indications. Subpopulations that are rare in the United States, such as patients with unresectable tumors, may be accessed in India. Neeman CR works with approximately 250 GCP investigators encompassing all the indications listed. For chronic diseases, these sites maintain active patient databases. FDA-Quality DataSince 2001, Neeman CR has managed more than 70 Phase I-IV clinical trials for international companies ranging from small Biotech to large Pharmaceutical industry. More than 50 of these clinical trials contributed Indian data to FDA submissions. In many of them Neeman CR provided the recruitment boost required to complete the study.

How to explain Neemanities?

Neemanities are like the bikers of a metro city who find/creates their own way even in a heavy traffic jam considering the value of red light.

SapMaker

What is SapMaker?
SapMaker is a tool for helping users efficiently make Statistical Analysis Plans (SAP) for clinical trials. It will provide the users easily-to-use features to efficiently create Word document of SAP with table and figures shells, SAS programs of the tables, and metadata document of analysis datasets

Sap Maker

Who should use SapMaker?
Biostatisticians, Statistical Programmers, and Medical Writers who are working on clinical trials.

If you are a biostatistician working at a pharmaceutical or biotechnique company, this is a must have tool for you.

Major Features
· Provide instructions for writing contents of Statistical Analysis Plan (SAP), Clinical Study Report (CSR), and Clinical Study Protocol.
· Write selected sections of the SAP, CSR, and Protocol into a Microsoft Word document;
· Can use this tool to quickly create table shells (mock tables) in a Microsoft Word or Excel document, and mock figures in a Word document.
· Include a easy-to-use editor to modify or develop templates for SAP/CSR/Protocol contents, SAP mock tables and figures.
· Can use this tool quickly create SAS code to generate the table by using an easy-to-use editor to extract metadata of the template.
· Can use this tool quickly create metadata document following the standards of the Clinical Data Interchange Standards Consortium (CDISC) included Operation Data Model (ODM), Study Data Tabulate Model (SDTM), and Statistical Analysis Dataset Model (ADaM)
· Can create SAS program template for creating a dataset based on the metadata. document (in an Excel document).
· Can transfer metadata document to define.XML document following CDISC standards.
Requirement
· Supported Operating Systems: Windows Family.
· Software Requirements: Microsoft Word or Microsoft Excel.

Synergy Creates Alliance With Indian CRO Neeman Medical

Russian CRO Synergy Research Group (SynRG) has made its next move to create a global CRO alliance, forming a partnership with Neeman Medical International, an India-based CRO. The alliance will focus on providing international sponsors with monitoring and site and data management services. Neeman Medical was founded in 2001 and is headquartered in New Delhi.
The CRO has about 70 investigative sites in 17 locations across the country, with access to more than 600 trained investigators.

Clinical Data Management and Role of Bio-statistician

Introduction on CDM

Clinical Data Management plays a significant role in Clinical Trials to ensure the integrity and quality of data being transferred from trial subjects to a database system
· To provide consistent, accurate and valid clinical data
· To support accuracy of final conclusions and report
· CDM refers to management of data capture & data flow processes in conduct of a clinical research
· It begins with design of data capture instrument & data collection, continues with data QC procedures to assure quality of all aspects of process and ends with database finalization

Objectives of CDM

To ensure:
· That collected data is complete and accurate so that results are correct
· That trial database is complete, accurate and a true representation of what took place in trial
· That trial database is sufficiently clean to support statistical analysis, its subsequent presentation & interpretation

Role of Bio-statistician

The primary attributes of biostatistician can be defined in the following terms:
should be collaboration and not simply consulting or controlling
should be guided by commitment and taking responsibility
requires patience and tolerance but also firmness

The Bio-statistician not only plays a major role as data analyst but should also be involved beforehand in the study’s design and conduct and should be a collaborating scientist in ensuring that both protocol design and the interpretation of trial findings conform to sound principles.

The Bio-statistician should make a statistical model to help the sponsor, CRO and / or the Investigator in writing the Protocol. The number of subjects to be included in the study is determined in relation to the statistical model on which the protocol is based. The involvement of an appropriately qualified and experienced statistician is necessary in planning as well as throughout the study which includes study design and statistical analysis.

Streamlined Clinical Development

The Streamlined Clinical Development (SCD) solution aims to establish optimized processes and systems for drug development that will help you take drugs to market faster, safer and cheaper. Currently, the clinical development phase is the most time consuming and costliest in the R&D process, with the average cost per drug being above $200 million, and time taken anywhere from 6-8 years. Causing, and/or contributing to the inefficiencies of the process are various issues such as:

· Difficulty in integrated clinical development planning
· Increasingly rigorous regulatory requirements and increased cost due to more complex trial requirements (e.g., more patients per trial, need to cover multiple populations & strata)
· Difficulty in patient recruitment
· Multiplicity of systems, poor site infrastructure, and lack of industry standards
· Accessing real-time, accurate trial data
· Lack of integrated view of Clinical, Lab and Safety data for the CRO as well as the Sponsor
· Complying with 21 CFR Part 11, GCP requirements
· Managing adverse event reporting
· Stringent FDA requirements
· Delays in submission and approval
· Large volumes of documents
· Difficulty in budget, resource, project management

The SCD solution addresses these 'pain points' by optimizing workflows, increasing real-time data access, and enhancing data quality & decision-making through the drug development value chain. The components of the SCD solution are:
· Domain and technical consulting spanning the development value chain
§ Process re-engineering for clinical research groups
§ Research-IT mapping to capture workflows and align supporting systems
§ Regulatory compliance consulting (21 CFR 11, CSV, cGCP, etc.)
· Clinical data management
§ Oracle Clinical - Version 4.0 & 4.5
§ Adverse event reporting systems
§ Remote data capture
§ Thesaurus management systems
· Document management
§ Workflow and lifecycle optimization
§ Content reuse to improve effectiveness
· Clinical trial project management
§ Customize horizontal project management platforms for clinical development
· Central lab management
§ Bid, Kit, Sample management, Study setup, Lab data management
§ Data validation for lab data
§ Integration with LIMS
§ Telemedicine data management and interpretation
· Pharma CRO integration
§ Trial status dashboard for the sponsor
§ Collaboration tools across Pharma-CRO interface
· Regulatory compliance
§ 21 CFR Part 11 compliance
§ Validation services - IQ, OQ, PQ
The SCD solution leverages Oracle and Documentation as preferred partners for specific components.