Clinical Development

STRIVING FOR OPERATIONAL EXCELLENCE, ENSURING SUPERIOR DELIVERY

Conducting clinical trials is a meticulously coordinated endeavor—rely on KLCRO to execute each trial with operational excellence. KLCRO collaborates with biopharmaceutical and biotech firms, investigators, site personnel, laboratories, technology vendors, and regulatory authorities, ensuring a collective commitment to patient safety and accessibility at every stage of research. Each participant contributes to delivering high-quality data that propels promising compounds forward

Clinical Operations/projects Consultancy

Research Study Development

Multi-centered Study Management

OUTPERFORMING TIMELINES IS A MAJOR DRIVING FORCE FOR US

With extensive experience in medical devices and regulations, we offer valuable assistance in saving both time and money. Our expertise spans the intricacies of both domestic and global markets and our offices in Pakistan provide localized insights to facilitate the approval process for your devices. Collaborating with physicians and seasoned consultants, we ensure adherence to International and  National regulations throughout the development of medical devices.

Our services encompass:

  1. Submission to the DRAP-Medical devices divison.
  2. Preparation, attendance, and follow-up for MDMC meetings.
  3. Auditing and ensuring compliance with quality assurance standards
  4. Designing and assessing quality systems and assistance in SOPs.
  5. Employee training and document control.

HEALTH DIGITALIZATION

A Continued Focus on Site Digitization and Always-on Connectivity

Digitalizing workflows at every site and establishing always-on connectivity between sites and sponsors will remain a core focus in 2024, which has been on everyone’s priority list since 2020.

Sponsor mandated portals failed to accomplish the goal in the past so now the focus has shifted to Site Enablement, which emerged as a key goal in 2023. Site Enablement emphasizes the enhancement of the site experience and the enhancement of workflows as the cornerstone of technology implementations.

We are among the early adopters of this strategy that have seen significant progress in the clinical research studies; achieving faster timelines, increased capacity, and significant risk reduction across portfolios.

HEALTH DIGITALIZATION

A Continued Focus on Site Digitization and Always-on Connectivity

Digitalizing workflows at every site and establishing always-on connectivity between sites and sponsors will remain a core focus in 2024, which has been on everyone’s priority list since 2020.

Sponsor mandated portals failed to accomplish the goal in the past so now the focus has shifted to Site Enablement, which emerged as a key goal in 2023. Site Enablement emphasizes the enhancement of the site experience and the enhancement of workflows as the cornerstone of technology implementations.

We are among the early adopters of this strategy that have seen significant progress in the clinical research studies; achieving faster timelines, increased capacity, and significant risk reduction across portfolios.

DATA-DRIVEN APPROACH

At KLCRO, accurately predicting how well a site will perform is crucial in our process of choosing Clinical Trial Units (CTUs). We don’t rely solely on surveys and unreliable methods, crossing our fingers that the sites will have the necessary patients. Instead, we use real time data to swiftly inform our decisions on site selection and recruitment planning.”

MORE CLINICAL DEVELOPMENT CAPABILITIES

Clinical Operations/projects Consultancy
Product Development and Consulting
Phase II-IV Clinical Trial Management
Medical Device Development
Pre and Post Product-Approvals
Multi-centered Study Management
Functional Service Partnership Solutions
Clinical Trial Units (CTUs) Services
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