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Clinical Trial Support Services

In today's competitive pharmaceutical landscape, navigating the complex process of clinical trial regulations can be challenging. Clinical trials are resource-intensive, from study design and compliance with regulatory guidelines to patient access, timeline maintenance, and cost management. A seasoned, efficient, and effective clinical trial support will help you optimize time and cost while delivering operational and scientific excellence.
With 24+ years of expertise in Healthcare BPO Services , Suma Soft’s Clinical Trial Support Services ensures your clinical trials run smoothly and efficiently. Leveraging advanced tools and technologies, our skilled, knowledgeable team manages every aspect of the process, from initial regulatory strategy development to final study report submission. Now, your team can focus on groundbreaking research – while we handle all the regulatory complexities using the latest methods!
Our clinical trial support services assist you in adhering to all relevant regulations established by the FDA and international agencies. Achieve patient safety, maintain data integrity, and ensure better clinical outcomes with regulatory compliance:

Patient Safety First

Prioritize the safety and well-being of patients participating in research by establishing ethical practices and minimizing potential risks.

Data Integrity

Regulatory compliance promotes accurate and reliable data collection, validating your research findings.

Patient Safety First

Prioritize the safety and well-being of patients participating in research by establishing ethical practices and minimizing potential risks.

Data Integrity

Regulatory compliance promotes accurate and reliable data collection, validating your research findings.
Suma Soft’s technology-enabled clinical trial solutions offer faster patient recruitment, better retention, accurate patient data capture, improved data access, and enhanced patient and trial management. With highly qualified and experienced professionals, our understanding of the latest guidelines and best practices ensures your trials adhere to all relevant requirements. Our clinical trial support services recognize that every trial is unique and develop customizable strategies to achieve regulatory goals for different trial procedures.
Suma Soft helps organizations to digitize their clinical trial practices. Our advanced solutions and cutting-edge technology assist organizations with end-to-end aspects of planning, executing, and deploying clinical trials. Our comprehensive clinical trial support services are designed to meet every need from inception to execution.
CTA Submissions and Expert Consultation

CTA Submissions and Expert
Consultation

All aspects of your Clinical Trial Application (CTA), from Chemistry, Manufacturing, and Controls (CMC) documentation to providing legal insights into new regulations that might impact any phase of your clinical program are accurately managed by our clinical trial support service team.
Strategic Initial CTA Preparation and Management

Strategic Initial CTA Preparation and Management

By providing customized checklists and expert assistance in crafting region-specific CTAs, our clinical trial support service team facilitates seamless interaction with regulatory and local authorities, ensuring your CTA meets the requirements of that region.
Ongoing CTA Maintenance Support

Ongoing CTA Maintenance Support

Need help maintaining compliance? Our clinical trial support services review new or updated documentation and answer any questions about your CTA. Our team assists with preparing and submitting both non-substantial and substantial amendments to keep your application current throughout the trial.
Efficient CTA Completion and Closure Management

Efficient CTA Completion and Closure Management

With the culmination of your trial, our clinical trial support services prepare and submit end-of-trial notifications and detailed study reports. We also provide post-trial overviews and archive information to ensure regulatory compliance for a smooth closure.
Custom Regulatory Strategy Formulation

Custom Regulatory Strategy
Formulation

Our clinical trial support service team assists you in crafting a regulatory strategy that suits your clinical trial objectives. Organizations can focus on research efforts while we evaluate the regulatory landscape of their target markets and create a roadmap for compliance throughout each trial phase.
Comprehensive Training and Ongoing Support

Comprehensive Training and Ongoing Support

We provide your internal team with training sessions on regulatory requirements and best practices to remain updated on the latest regulatory developments and effectively communicate with regulatory authorities.
Our clinical trial support services follow a simplified and seamless step-by-step process to streamline your clinical trials. By leveraging cutting-edge technology and efficient document management processes, we digitize trial processes to optimize research, ensure participant flexibility, and improve trial outcomes. Our streamlined approach ensures quick and compliant clinical trial execution:

In-depth Consultation

Our clinical trial support service teams begin by understanding your clinical trial objectives, target markets, and regulatory requirements.

Regulatory Strategy Development

Considering timelines, budget, and regulatory expectations, our clinical trial support service team develops a customized regulatory strategy tailored to specific needs.

Regulatory Document Preparation

We ensure compliance with local and international regulations by preparing all required regulatory documents, including CTAs, clinical study reports, and safety reports.

Regulatory Submission and Tracking

Our clinical trial support services efficiently submit regulatory documents to the relevant authorities and monitor the review process closely, ensuring timely responses and addressing queries.

Regulatory Compliance Monitoring

With evolving regulatory guidelines, our clinical trial support services ensure ongoing compliance throughout the trial.

Post-Trial Regulatory Activities

With the culmination of the trial, our clinical trial support service team assists with end-of-trial activities, like final report submission and archiving, and ensures a smooth closure of your clinical trial.
In an ever-changing regulatory landscape, Suma Soft’s clinical trial support services offer assistance with complex documentation, evolving guidelines, and adherence to international regulations. Utilizing advanced tools and skilled clinical research regulations experts, our clinical trial support services provide faster turnaround times and improved document preparation and submission accuracy for clinical research organizations. Partner with Suma Soft for a clinical trial journey that saves you valuable time and resources, allowing you to focus on research efforts.
Deep Regulatory Expertise

Deep Regulatory Expertise

With extensive knowledge of global regulatory requirements, our clinical trial support service team of experts ensures compliance and minimizes risks.
Proven Track Record

Proven Track Record

We have a successful track record of supporting numerous clinical trials across various therapeutic areas.
Client-Centric Approach

Client-Centric Approach

Working closely with our clients, our clinical trial support service team analyzes an organization’s unique needs to customize our services accordingly.
State-of-the-Art Technology

State-of-the-Art Technology

Leveraging cutting-edge technology, our clinical trial support services streamline clinical processes to improve efficiency.
Dedicated Project Management

Dedicated Project Management

Our dedicated project managers oversee every aspect of the project, ensuring timely delivery and effective communication.
Cost-Effective Solutions

Cost-Effective Solutions

With competitive pricing and flexible engagement models, our clinical trial support services are designed to fit into every budget size.

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