Going Beyond

What’s Possible

We work closely with our clients and participate in their successful completion of the initiatives. Our clients can depend on our services to achieve their outcomes by continuously understanding the dynamics of the ecosystem and staying focused on outcomes. Our ability to scale quality and customer focus, ensures that outcomes are positive and as designed.

Key areas of our Expertise

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Works in partnership with drug development project leaders to develop, gain approval, and execute on the project strategy.

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Co-chairs timely, efficient, and action-oriented Development Project Team meetings and is responsible for coordinating team operations and communications.

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Directs highly complex project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.

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Organizes preparation of high-quality documents for review by governance committees in collaboration with the project team and represents the Development Project Team at Governance meetings, when needed.

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Organizes the formation of Project Teams and Request for Development (RFD) Teams with leadership of the functional areas, and guides transition of projects between development phases.

Our Best Services

Clinical
Data Operations

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Study start-up including site identification, qualification, and selection.

Study document development.

Essential document collection and maintenance.

Trial Master File set-up and maintenance.

Site monitoring and management.

Patient recruitment and retention strategies.

Clinical trial management system.

CRA management and quality control.

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Biometrics

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Our Statisticians support all phases of clinical trial start from protocol development to CSR and also involved in agile trends in clinical Statistics such as Adaptive design, innovative way to represent data by avoiding redundant analysis.

Data Management Data

Biostatistics & Programming

Medical Writing

Data Management Accreditation

Scientific Writing

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Informed consent forms and patient information leaflets.

Clinical study reports (full, abbreviated, interim, and synoptic)

Protocols and amendments.

Investigational medicinal product dossiers (IMPDs)

Patient-level and event-level safety narratives

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Regulatory Affairs

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Cultivating relationships with Key Opinion Leaders (e.g., healthcare practitioners, academic researchers, experts in defined therapeutic areas).

Formulating scientific strategy.

Reviewing the clinical trial proposals.

Defining a publication plan for each product.

Process Improvement & Change Management

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Our process standardisation is followed in four major steps, that are Productivity, Quality, Time and Cost.

Gap Analysis

Process Agility assessment and recommendations

Implement Process Change and alignment

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Best Security

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Expedited & Periodic Reporting QPPV Office Support & Consulting.

Case Processing

Working from CRF review to till submissions, our statistical programmers are experts in regulatory guidance (CDISC standards) and provide the right level of expertise and experience to ensure quality project deliverables.

Dossier
Lifecycle Management

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E Submission Authoring Tool are - 1 Product, 1 Country, 1 Sequence

Management of Submission Activity.

Variants for Other Countries.

Variants for Other Dosage/ Form/ Indication.

Management of the Submissions for all Portfolios.

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Resourcing Process

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Selection of Resources with a strong track record.

Thorough phone screening.

Technical Screening.

Background Checks.