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Clinical Operations

At DiagnoSearch, Clinical Operations are built on a strong scientific foundation, meticulous planning, and disciplined execution aligned with global regulatory expectations. We recognise that every clinical trial is uniquely important and demands focused oversight, accountability, and consistency from study start-up through close-out.

Our Clinical Trial Operations are led by experienced DiagnoSearch professionals and supported by dedicated cross-functional teams who bring clarity, control, and continuity at every stage of the trial lifecycle.

What We Offer

DiagnoSearch delivers end-to-end Clinical Research Operations, designed to support studies across phases, indications, and geographies.

Comprehensive Clinical Trial Management

  • Feasibility assessment and site selection
  • Core documents review and finalization
  • Regulatory support and submissions
  • Project and site Management
  • Monitoring - Site Initiation, Site Monitoring and Close-out

Investigational Product Management

  • Preparation of Investigational Product Management Plan
  • Finalization and coordination with comparator procurement partners
  • Finalization and management of labelling and packaging vendors
  • Supply forecasting and site inventory management and subject progression

Third Party Vendor Management

  • Evaluation of vendors
  • Vendor management
  • Vendor audits
Clinical Operations

How We Enable Efficient Start-Up

Our Clinical Research Operations teams are engaged early from initial sponsor discussions to enable efficient planning and faster study activation. Each study is led by a dedicated Project Manager who serves as the single point of contact. This is supported by cross-functional teams, robust internal processes, and technology-enabled workflows like eTMF, ensuring visibility, coordination, and timely execution. Key start-up activities include:

  • Development and approval of core study documents
  • Finalization of Informed Consent Documents and translations management
  • Resource allocation and study specific training
  • Site identification and qualification
  • Collation of Site Regulatory Package documents
  • Regulatory Dossier preparation, submissions and follow up till approval
  • Ethics Committee submission and follow up till approval
  • Study Plans (Risk Management Plan, Project Management Plan, Monitoring Plan, Communication Plan, Study Manual, Investigational Product Management Plan)
  • Review of Case Report Forms, IWRS specifications
  • Site budgets and Clinical Trial Agreements
  • Investigator Meeting planning and execution
  • Procurement and distribution of Clinical Trial Supplies
  • Selection and management of third party vendors  

The DiagnoSearch Approach to Clinical Operations

Scientific & Strategic Site Selection
DiagnoSearch maintains a robust investigator database and long-standing site relationships. Sites are evaluated for infrastructure, experience, past performance, and recruitment potential using a structured, scientific approach. Our historical variance between projected and actual recruitment remains below 5%.
Role-Based Site Training & Compliance
In addition to investigator meetings and initiation visits, DiagnoSearch deploys role-based, project-specific training modules with evaluation and certification. “Train-the-Trainer” and web-based models have proven effective for large, field-based, and long-duration studies, ensuring consistent and compliant trial conduct.
Strict adherence to timelines
Across a majority of studies, DiagnoSearch meets or exceeds planned start-up and recruitment timelines, a testament to disciplined execution and proactive planning across Clinical Trial Operations.
Aligned Data Expectations
Our “Right the First Time” approach prevents unforeseen challenges and re-work during execution. From the outset, we align sponsors, sites, and internal teams on data capture and presentation requirements, minimizing rework and facilitating clean database locks.

Global Reach

DiagnoSearch is headquartered in India, with registered offices in the United States, South Africa, Kenya, and Malaysia. While our core Clinical Operations teams are based at our headquarters, we have teams locally in Bangladesh and several African countries, ensuring last-mile reach and in-country oversight where it matters most. Through partnerships, we support trials in Thailand, the Philippines, and Australia.

Our presence enables clinical operations services across APAC and Africa, providing access to nearly one-third of the world’s population while maintaining consistent quality and regulatory alignment.

The DiagnoSearch Advantage

Our approach combines three decades of experience with structured processes and committed teams ensuring trials move forward with clarity and control.

Experience that translates into execution

With over 30 years in clinical research, our Clinical Trial Operations teams bring practical insight across phases, indications, and geographies. This experience enables informed decision-making and consistent delivery, even in complex study environments.

End-to-end accountability

Each study is led by a dedicated Project Manager who serves as a single point of contact, supported by cross-functional experts across Clinical Research Operations. This structure ensures accountability, transparency, and continuity throughout the trial lifecycle.

Global reach with local execution

Headquartered in India with teams and partners across APAC, Africa, and other regions, DiagnoSearch combines global oversight with in-country execution delivering consistent quality across geographies.

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