Our Site Monitoring Operations (SMO) has one of the largest networks of investigators, investigative sites and maintains high retention of our clients due to our commitment, responsiveness, flexibility and performance.
Site feasibility

 

• Site feasibility is an integral and critical initial step in the conduct of any clinical trial efficiently. By assessing potential investigators at the site level, we have a more accurate analysis of their workload and competing studies.
• Specializing in global patient recruitment, we start by accurately identifying target patient populations through feasibility and implementing cost-effective strategies and tactics to complete enrollment on time.
• The investigators and sites undergo a robust feasibility survey process experience which leads to ‘on target’ completion and lesser delays than those who do not undertake such assessments
• We perform feasibility in these three critical areas – Ethics, Quality and Expertise
• Site selection- We have access to more than 100 multispecialty Hospital Networks across PAN India.

 

Our site selection criteria includes:

• Ethics Committee Registered Site by CDSCO with maximum patient pool​.
• Timer Period of EC meeting to fasten EC approval for clinical trials
• Cost effective EC meeting fees
• Experienced DCGI audit qualified clinical trial site
• Well-equipped infrastructure with clinical trial specific requisite which includes an experienced clinical trial team, logistics, clinical trial material and IP storage unit, NABL accredited Lab / Out-sourcing Lab Vendor Tie-up and Archival Unit
• Investigator mapping
• Nearly 300 investigators & investigative sites located in more than 25 cities across India. Each investigative site is supported by a full-time study coordinator. Over 130 data points are collected and evaluated for each site.
• Clinical trial investigator database Nucleon is generated by mapping investigators as per Therapeutic Area Investigator Selection Criteria

1. ICH-GCP trained & clinical trial experienced​
2. Maximum patient pool
3. Completing patient recruitment within the timeline
4. Conducts clinical trial within sponsors budget
5. Providing assistance for DCGI audit

 

• Maintenance of study archived material as per EC SOP
• Resolve discrepancies raised by Clinical Data Management
• Ensuring completion of clinical study in compliance with local regulatory and ICH-GCP guidelines within the timeline

Nextrove provides end to end clinical operation services from site feasibility to Clinical Study Report Submission. Our services are conducted in adherence with the latest GLP, ICH-GCP and 21 CFR (part 11) and all other applicable regulatory guidance. Our Clinical Operation team is highly experienced and efficient for the successful execution of clinical trials as per client’s requisite

 

Our CRAs are experienced in numerous therapeutic areas across drug, biologic and device trials. All of our CRAs have state-of-the-art communication tools in place to provide timely and responsive communication, data accessibility and centralized tracking and management of procedures. All monitoring activities are conducted with data integrity during each site visit, consistently retrieving high quality, on-time data.

 

Nextrove’s clinical monitoring team ensures adherence with standard operating procedures (SOPs) and strives to promote positive personal relationships with a high level of trust and confidence with all our clients. Our CRCs are assigned to specific sites for the duration of the study to provide consistent support to the sites. Our Clinical Trial Assistants (CTAs) acts as the liaison between sites and the study team.

Nextrove is capable of performing data management activities with eCRF or paper CRF and provides high-quality data and on-demand statistical programming services. Our data management staff are also diverse in clinical operations and IT, while our bio-statistics team has working knowledge of the clinical/ medical operations, data management, and IT environments. Our project leaders are experienced in directing multiple concurrent studies of established and startup biomedical companies.

 

Our team has a wide range of experience and has performed data management and statistical analysis for various studies in a variety of therapeutic areas in all phases of drug development. We customize our services to flexibly accommodate your end-to-end data management and specific needs. Our team can also provide guidance on the selection of an EDC system based on your study requirements and budget.

 

Our experts work in partnership with sponsors and investigators/sites to cover data collection, database setup and maintenance, data entry, data cleaning and storage in compliance with regulatory submission requirements and project objectives. We use ClinSoftV1.0 and Medra Version 21.0 for CDM and biostatistics​.

 

Data Management Services include:

 

• Study conduct
• Study setup
• Protocol Development​
• CRF Design, Production & CRF Review
• Data Management Plan development
• Edit Checks & Data Validation Specs
• IVRS Setup & Integration
• Database Testing & UAT

Nextrove has vast experience and global exposure in providing high quality clinical study documents which are compliant with regulatory requirements and ICH E3 guidelines. Our experienced medical writers have experience working in a broad range of indications and therapeutic areas. We can assist at any time in the product development from Phase I to Phase IV.

 

Our clinical writing process involves a sequence of scientific, statistical and editorial management, and quality control reviews at each developmental step. From the initiation of a project to the final documentation, Nextrove maintains a high level of communication with clients, ensuring that the document content and format fully meets your expectations and requirements.

 

Nextrove’s medical writing services include clinical and regulatory writing as well as scientific communications, educational material and medical writing consulting.

 

• Clinical Study Protocol and Protocol Amendments
•  Clinical Study Reports (full and abbreviated)
•  Disclosure summaries
•  Informed consent documents
•  Patient safety narratives
•  Common Technical Document Modules (2.4, 2.5, 2.6 and 2.7)
•  Non-clinical summaries and non-clinical overview (M 2.4 & 2.6) documents for e-CTD submissions
•  New drug application (NDA) and Investigational new drug application (INDA)
•  Development safety update reports & Periodic safety update reports (DSUR, PSUR)
•  Investigator Brochure

Nextrove provides regulatory services to facilitate all stages of drug development by providing interdisciplinary strategy planning to obtain the most effective and efficient regulatory pathway towards regulatory authorizations. We customize our services as per client and regulatory requirements. With our expertise, we provide a wide range of regulatory writing services and project management services covering key therapeutic areas across clinical and post marketing stages.

 

Regulatory services include:

 

• Regulatory Consulting
•  Regulatory Operations
•  Electronics Submissions/eCTD
•  Regulatory Agency Liaison
•  Regulatory Due Diligence
•  Device Classification and Strategy
•  Critical Literature Review
•  Report Preparation/Publishing/Submission
•  Regulatory Intelligence Center
•  Post-submission support (e.g., annual reports, amendments, variations)