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Secure & Compliant Pharma Outsourcing Services

Accelerate your time-to-market and reduce operational costs with our FDA & HIPAA-compliant BPO solutions. Expert teams, scalable processes, and uncompromising data security.

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CMMI Level 5 CertificationISO 27001 CertificationSOC 2 CompliantPCI DSS Certified
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Trusted by Global Leaders and Innovators in Life Sciences

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Why Partner with LiveHelpIndia for Pharma Outsourcing?

In an industry where precision, security, and compliance are non-negotiable, we provide more than just outsourcing; we deliver peace of mind and a strategic advantage.

Unwavering Compliance

Our operations are built on a foundation of strict adherence to global pharmaceutical regulations, including FDA (21 CFR Part 11), EMA, and HIPAA standards.

Ironclad Data Security

With ISO 27001 and SOC 2 certifications, we guarantee the highest level of data protection for your sensitive clinical trial data and intellectual property.

Deep Domain Expertise

Our teams consist of life science graduates, pharmacists, and medical professionals who understand the nuances of the pharmaceutical landscape.

Scalable Operations

Seamlessly scale your support team up or down based on your clinical trial phases, product launch schedules, or market demands, ensuring optimal resource allocation.

AI-Powered Efficiency

We leverage AI and automation to enhance accuracy in data management, accelerate reporting, and provide predictive insights, reducing manual errors and saving time.

Significant Cost Optimization

Reduce your operational overhead by up to 60% without compromising on quality, allowing you to reinvest savings into core R&D and innovation.

24/7 Global Support

Our global delivery model ensures continuous, round-the-clock support for your operations, from pharmacovigilance monitoring to patient support services.

Transparent Reporting

Gain full visibility into your outsourced operations with real-time dashboards and customized reports, ensuring you are always in control.

Proven Track Record

With over two decades of experience, we have a long history of successfully supporting pharmaceutical and biotech companies of all sizes, from startups to global leaders.

Comprehensive Pharma Outsourcing Services

We offer a full spectrum of services designed to support every stage of the pharmaceutical lifecycle, from pre-clinical research to post-market surveillance. Our solutions are tailored to meet your specific needs, ensuring seamless integration and maximum impact.

Pharmacovigilance Services

Ensure patient safety and regulatory compliance with our end-to-end pharmacovigilance support, from case processing to aggregate reporting.

  • Adverse Event (AE) case processing and reporting.
  • Literature screening and signal detection.
  • Periodic Safety Update Reports (PSURs) preparation.

Clinical Trial Support

Streamline your clinical trials with our comprehensive support services, designed to improve efficiency and data quality from startup to closeout.

  • Clinical data management and validation.
  • Trial Master File (TMF/eTMF) management.
  • Site coordination and administrative support.

Medical Writing & Reporting

Access expert medical writers for clear, concise, and compliant documentation required throughout the drug development lifecycle.

  • Clinical study reports (CSRs) and protocols.
  • Investigator's Brochures (IBs) and manuscripts.
  • Regulatory submission documents.

Regulatory Affairs Support

Navigate the complex global regulatory landscape with our expert support, ensuring timely submissions and compliance with health authority requirements.

  • Dossier preparation and submission (e.g., CTD/eCTD).
  • Regulatory intelligence and strategy.
  • Lifecycle management of approved products.

Quality Assurance & Compliance Audits

Maintain the highest standards of quality across your operations with our independent QA services and audit support.

  • GCP/GMP/GLP compliance checks.
  • Internal and external audit preparation.
  • SOP development and review.

Healthcare Data Management

Leverage our expertise in managing large volumes of complex healthcare data, ensuring accuracy, security, and accessibility for analysis.

  • Data entry, cleansing, and validation.
  • Database design and management.
  • Data migration and integration services.

eTMF Management

Ensure your Trial Master File is inspection-ready at all times with our meticulous eTMF management services.

  • Document processing and quality control (QC).
  • TMF health checks and completeness tracking.
  • Archiving and maintenance.

R&D Support Services

Accelerate your research and development efforts by outsourcing non-core scientific and administrative tasks to our specialized teams.

  • Scientific literature search and analysis.
  • Patent research and support.
  • Lab data entry and management.

Medical Billing and Coding

Optimize your revenue cycle with accurate and compliant medical billing and coding services tailored for clinical research and healthcare providers.

  • ICD-10, CPT, and HCPCS coding.
  • Claims submission and denial management.
  • Compliance with payer regulations.

Back-Office & Administrative Support

Free up your internal teams by outsourcing essential administrative functions, from finance and accounting to human resources.

  • Invoice processing and financial reporting.
  • HR administration and payroll support.
  • Procurement and vendor management.

Medical Information Call Center

Provide accurate and timely information to healthcare professionals and patients with our 24/7 multilingual medical information services.

  • Handling product inquiries and requests.
  • Adverse event intake and reporting.
  • FAQ management and response.

Patient Recruitment & Retention Support

Enhance your clinical trial enrollment and engagement with our targeted patient outreach and support services.

  • Pre-screening and patient qualification calls.
  • Appointment scheduling and reminders.
  • Patient support programs and helpdesks.

Supply Chain & Logistics Support

Ensure the efficient management of your pharmaceutical supply chain, from clinical trial materials to commercial distribution.

  • Order processing and fulfillment.
  • Inventory management and tracking.
  • Logistics coordination and support.

Sales & Marketing Support

Empower your commercial teams with our back-office support, enabling them to focus on building relationships and driving growth.

  • CRM data management and hygiene.
  • Lead qualification and appointment setting.
  • Marketing material compliance review.

AI-Powered Data Analytics & Insights

Transform your clinical and commercial data into actionable intelligence with our advanced analytics and machine learning capabilities.

  • Predictive modeling for patient outcomes.
  • Real-world evidence (RWE) analysis.
  • Commercial effectiveness dashboards.

Leveraging AI to Future-Proof Your Pharma Operations

We are not just a BPO provider; we are a technology partner. We integrate advanced Artificial Intelligence and Machine Learning into our services to drive unprecedented levels of efficiency, accuracy, and insight.

  • Intelligent Automation: Automate repetitive tasks like data entry and case processing, reducing human error by over 95% and freeing up your experts for high-value work.
  • Predictive Analytics: Utilize AI models to forecast clinical trial recruitment rates, identify potential safety signals earlier, and optimize supply chain logistics.
  • Natural Language Processing (NLP): Extract critical information from unstructured text, such as electronic health records and scientific literature, to accelerate research and pharmacovigilance.
Discover Our AI Solutions
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Proven Success in Pharma & Biotech

Don't just take our word for it. See how we've helped companies like yours overcome challenges and achieve their goals.

Scaling Pharmacovigilance for a Phase III Trial

Industry: Mid-Sized Biotechnology

Client Overview: A rapidly growing biotech firm was entering a large-scale, global Phase III clinical trial for their lead oncology drug. Their small in-house pharmacovigilance (PV) team was unprepared for the anticipated surge in adverse event (AE) volume, threatening reporting timelines and regulatory compliance.

"LiveHelpIndia didn't just provide bodies; they gave us an expert, scalable PV team that integrated perfectly with our own. Their performance was flawless and allowed us to focus on a successful trial submission."

Dr. Anya Sharma, VP of Clinical Operations, OncoTherapeutics Inc.

Key Challenges & Solutions

  • Challenge: Lack of scalable AE case processing capacity.
    Solution: Deployed a dedicated, trained team of 15 PV specialists within 4 weeks.
  • Challenge: Ensuring consistent global compliance.
    Solution: Implemented a 24/7 "follow-the-sun" model for continuous case processing and reporting.
  • Challenge: Maintaining high data quality standards.
    Solution: Utilized AI-powered tools for initial data extraction and quality checks before expert review.
  • Challenge: High cost of hiring specialized local talent.
    Solution: Provided a cost-effective offshore model without compromising on expertise.
40% Reduction in PV Operational Costs
99.8% Accuracy in AE Case Processing
100% On-Time Regulatory Submissions

24/7 Medical Information Support for a New Device Launch

Industry: Medical Device Startup

Client Overview: A venture-backed startup was launching an innovative wearable glucose monitor in the US and EU markets. They needed to establish a reliable, multilingual medical information call center to handle inquiries from both patients and healthcare professionals (HCPs) but lacked the infrastructure and capital to build one in-house.

"The launch was a huge success, and a major part of that was the incredible support from LiveHelpIndia. They handled a 5x spike in call volume without missing a beat and provided a fantastic customer experience."

David Chen, CEO, GlucoSense Medical

Key Challenges & Solutions

  • Challenge: No existing infrastructure for 24/7 support.
    Solution: Set up a fully operational, dedicated call center with trained agents in 6 weeks.
  • Challenge: Need for support in English, Spanish, and German.
    Solution: Staffed the team with certified bilingual and trilingual medical information specialists.
  • Challenge: Ensuring accurate and compliant responses.
    Solution: Developed a comprehensive knowledge base and response scripts in collaboration with the client's medical affairs team.
  • Challenge: Managing unpredictable call volumes post-launch.
    Solution: Implemented a flexible staffing model that could scale on demand to manage peaks.
95% Customer Satisfaction (CSAT) Score
Average Call Wait Time
30% Lower Cost Than Building In-House

Centralizing Clinical Data Management for a Global Pharma

Industry: Large Pharmaceutical Company

Client Overview: A top-20 pharmaceutical company was struggling with inefficient and fragmented clinical data management processes across dozens of studies and therapeutic areas. Data inconsistencies and slow query resolution times were delaying database locks and analysis.

"LiveHelpIndia transformed our data management function. By centralizing the process and introducing smart automation, they cut our query resolution time by more than half and significantly improved our data quality."

Maria Rodriguez, Global Head of Data Management, PharmaCorp

Key Challenges & Solutions

  • Challenge: Inconsistent data standards across studies.
    Solution: Established a centralized data management team to enforce standardized procedures (CDISC compliant).
  • Challenge: High volume of manual data queries.
    Solution: Implemented AI-driven data validation checks to automatically identify and flag potential errors.
  • Challenge: Lack of real-time visibility into data quality.
    Solution: Developed and deployed interactive dashboards for real-time monitoring of data metrics.
  • Challenge: Slow, manual reconciliation of external data (e.g., lab, imaging).
    Solution: Created automated data reconciliation workflows, reducing manual effort by 80%.
60% Reduction in Data Query Resolution Time
50% Faster Database Lock Timelines
45% Decrease in Data Management Costs

Security & Compliance: The Core of Our Operations

We understand that in the pharmaceutical industry, there is no margin for error. Our infrastructure, processes, and training are all designed to exceed the most stringent security and regulatory standards, protecting your data and your reputation.

HIPAA
FDA 21 CFR
ISO 27001
SOC 2
GDPR

Our Seamless Onboarding & Delivery Process

We've refined our process over two decades to ensure a smooth, transparent, and efficient transition, getting your outsourced operations up and running with minimal disruption.

1

Discovery & Scoping

We work closely with you to understand your exact requirements, challenges, and goals, defining clear KPIs and SLAs.

2

Team Selection & Training

We assemble a dedicated team with the right domain expertise and provide them with rigorous, client-specific training.

3

Technology & Workflow Integration

We securely integrate with your existing systems (e.g., EDC, Safety DB) and establish compliant, efficient workflows.

4

Pilot & Go-Live

We launch a pilot phase to ensure everything runs smoothly before scaling to full operational capacity.

5

Governance & Optimization

Through regular reporting and reviews, we provide full transparency and continuously seek opportunities to optimize performance.

Technology & Platforms We Master

Our teams are proficient in the leading pharmaceutical software and technology platforms, ensuring seamless integration and immediate productivity.

Meet Some of Our Pharma Service Experts

Our strength lies in our people. We employ a diverse team of seasoned professionals with deep expertise in technology, life sciences, and global business operations.

Avatar for Amit A.

Amit A.

Founder & COO, Ph.D.

Expert in enterprise technology solutions, ensuring robust and compliant systems for our pharma clients.

Avatar for Prachi D.

Prachi D.

Manager, AI & Cloud Solutions

Leads the integration of AI and machine learning to automate data processes and extract critical insights for clinical trials.

Avatar for Joseph A.

Joseph A.

Expert, Cybersecurity & Engineering

Architects our secure infrastructure, ensuring all client data is protected against threats and compliant with regulations.

Avatar for Dilip B.

Dilip B.

Manager, Customer Experience

Oversees our medical information and patient support services, focusing on empathetic and accurate communication.

Avatar for Vikas J.

Vikas J.

Divisional Manager, ITOps & SecOps

A certified ethical hacker ensuring our operational security meets the stringent demands of the pharma industry.

Avatar for Vishal N.

Vishal N.

Senior Data Scientist (AI/ML)

Develops predictive models and data analysis frameworks to support clinical and commercial decision-making.

What Our Clients Say

We're proud to be a trusted partner to innovative companies in the life sciences sector.

Flexible Engagement Models

We offer a range of engagement models designed to provide the flexibility, control, and value your organization needs.

Dedicated Team

An entire team of experts works exclusively on your projects, acting as a direct extension of your in-house staff. Ideal for long-term, complex needs requiring deep integration.

  • Maximum control and integration.
  • Deep knowledge retention.
  • Ideal for core, ongoing functions.

Managed Services

We take full responsibility for delivering specific outcomes and services based on agreed-upon SLAs. You define the 'what,' and we manage the 'how'.

  • Outcome-based and SLA-driven.
  • Reduced management overhead for you.
  • Perfect for well-defined processes.

Project-Based

Perfect for specific, time-bound projects with clear objectives, such as regulatory submission preparation or a data migration initiative.

  • Fixed scope, timeline, and budget.
  • Clear deliverables and milestones.
  • Ideal for one-off, defined needs.

Frequently Asked Questions

Have questions? We have answers. Here are some of the most common inquiries we receive from our pharmaceutical and biotech clients.

We employ a multi-layered security strategy. This includes ISO 27001 and SOC 2 certified data centers, end-to-end encryption, strict access controls, regular security audits, and comprehensive, ongoing HIPAA training for all staff handling sensitive data. All processes are designed to be fully compliant with regulations like FDA 21 CFR Part 11 and GDPR.

Our teams are specifically recruited for their life sciences background. Many hold degrees in pharmacy, biology, and other related fields. We provide extensive, ongoing training on pharmaceutical processes, GxP standards, and the specific therapeutic areas of our clients to ensure deep domain expertise.

Absolutely. Scalability is a core component of our service. We work with you to forecast resource needs and can rapidly scale teams up or down to match the demands of different clinical trial phases, product launches, or post-market activities, ensuring you only pay for the resources you need.

Our onboarding process is designed to be seamless and efficient. It begins with a deep-dive discovery phase, followed by team selection, client-specific training, and technology integration. We typically run a pilot program to fine-tune workflows before a full-scale launch, all managed by a dedicated project manager.

We believe in total transparency. We establish a clear communication plan with regular meetings (daily, weekly, monthly as needed) and provide access to real-time performance dashboards. You will have a single point of contact for all escalations and inquiries, ensuring clear and consistent communication.

Ready to Accelerate Your Pharmaceutical Innovation?

Let's discuss how our compliant, secure, and expert outsourcing services can help you reduce costs, improve efficiency, and focus on what matters most: bringing life-changing therapies to market.

Schedule a Free Consultation