CLINICAL OPERATION
Our clinical operations team is highly experienced and trained in effective site management services, ranging from feasibility study to study close-out. Collectively, the team has vast experiences in several therapeutic areas. We ensure the best clinical services, highest ethical standard and quality clinical data. Our Team is thoroughly trained in our SOPs, that meets the international standards. We are dedicated and ready to face all the challenges in the most complex journey of Drug Discovery, Clinical Trial, by taking it successfully through the crucial stages of obtaining the regulatory & ethics committee approval, study initiation, monitoring and study close-out.
PROJECT MANAGEMENT
At NexusCRO we consider our success in the success of our Clients project. We work as a strategic partner to complement your team. We are experienced in the management of clinical studies in all phases I-IV, in all major therapeutic indications.
NexusCRO’s Project Management ensures that all studies are carried out in full accordance with the study protocol, to agreed study timelines, and to other Sponsor-driven parameters. (ergomed) Nexus assigns a Clinical Project Manager to each study to communicate and manage all study activities and act as the primary liaison to the Sponsor who communicates the client’s needs to the entire project team and plan the trial design, execution strategy and set project team goals and timelines to align with the client's expectations.
Clinical Project Management Activities :
- Assure compliance with GCP and other regulations and guidelines.
- Maintaining primary contact with the Sponsor and Identifying sponsor goals and objectives.
- Selection of sites/investigators in agreement with the Sponsor.
- Selection and management of project team members (CRAs, as well as CTAs).
- Oversee study planning, implementation and close out throughout life cycle of study.
- Taking overall responsibility for all procedures and processes throughout the whole study period
- Project timeline management and tracking (global IQ & ergomed&averion)
- Establish lines and flow of communication with internal team members, the sponsor, and outside vendors.
- Establish agendas, organize and facilitates in person or online team meetings and communication (internal & external).
- Monitor study budgets and associated financial procedures and manages variances.
You can be sure you are working together with a highly efficient, experienced, dedicated, well trained and medically oriented team.
FEASIBILITY STUDIES AND SITE MANAGEMENT
A thorough feasibility and site selection is the basis of any successful clinical trial. Our feasibility group has worked on virtually every therapeutic area.
Our study feasibility assessment process is efficient and is capable of identifying the best investigative sites to conduct a clinical trial. Our custom designed feasibility questionnaires and tested processes are effective in predicting site success in implementing a given clinical trial.
The feasibility group works with clients to identify qualified principal investigators quickly from its site database, our experience, site reputation, and where appropriate, a site feasibility visit.
Feasibility and selection of sites :
- Maintaining Investigator database.
- Site infrastructure to meet study specification.
- Investigator's qualification, interest, experience and prior ICH-GCP trainings.
- Availability of site staff with adequate qualification and experience (ICH-GCP trained).
- Previous experience in similar clinical studies.
- Recruitment & retention in prior clinical trials.
- Trial-required facilities such as laboratories and pharmacies.
- Trial-specific equipment e.g. measuring and imaging .
- Additional sponsor requirements.
PROTOCOL DEVELOPMENT:
A well-designed set of Standard Operating Procedures (SOPs) can improve efficiency, lower costs, elevate compliance, clarify team roles, reduce training requirements, raise quality, improve safety, and enhance your ability to troubleshoot and correct problems.
NexusCRO's protocol development team, comprising of its highly skilled staff of Medical writers, Scientific panel members, therapeutic specialists, biostatisticians and project managers, ensures excellence in protocol development by focusing on the study design, target subject population, current medical practices, trial drug actions safety information, and compliance to ICH-GCP guidelines. Our experienced professionals apply their expertise to developing protocols specifically for your clinical trials.
Protocol development capabilities include :
- Relevant clinical/scientific considerations.
- Extensive feasibility
- Determination of sample size
- Statistical methodology
- Design compliance with worldwide regulatory guidelines
CLINICAL SITE MONITORING
NexusCRO provides comprehensive site monitoring and management. Our Clinical Research Associates (CRAs) act as the liaison between the sites and the study team. Our CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with GCP/ICH Guidelines and follows FDA/EMEA regulations. NexusCRO develops Sponsor-approved monitoring plan for each study. Monitoring visits are conducted at pre-determined intervals and/or as the study needs dictate.
Our CRAs are experienced in numerous therapeutic areas across drug, have state-of-the-art communications tools in place to provide timely and responsive communications, real-time data accessibility and centralized tracking and management of procedures.
Clinical Site Monitoring Services include: :
- Site Identification.
- Site Qualification and Initiation.
- Subject Accrual/Retention Strategy Enhancement.
- Regulatory Document Preparation and Collection.
- Budget and Contract Negotiation.
- Investigator Meeting Planning and Presentation.
- Site Personnel Training.
- Interim Site Monitoring.
- Clinical Study Material Accountability.
- Site Termination (averion).
REGULATORY AFFAIRS
We at NexusCRO, also provide consultation to our clients on :
- Methodology to approach the regulatory bodies.
- Regulatory submissions / Product registration dossiers.
- Time management (Faster Regulatory Approvals).
- An initial assessment of your data to maximize the possibility of rapid clinical trial approval
- Preparation of Regulatory Dossier.
- Regulatory strategy planning for faster approval.
- Filing of submissions, tracking submissions & query resolution.
- Post - approval regulatory submissions (amendments).
- Submission of final study reports.
- Preparation and submission of Product Registration applications, to import, manufacture and market in India.
- Complete Import & Export License Management for clinical supplies and biological product and samples.
- Collecting, reviewing and updating all national legislation related to clinical trials to ensure full compliance with all applicable.
- NexusCRO is familiar with Ethics Committee requirements. Its reputation for an active follow-up of protocol submissions ensures fast turn-around time.
- Familiarity with local requirements and practices is important in avoiding unnecessary delays when embarking on studies. With extensive experience in obtaining IRB/IEC approvals, NexusCRO professionals bring these assets to your clinical development programmes.
(Asiatic clinical)We support our client's product development programs by playing a pivotal role in obtaining regulatory approvals in the shortest possible time. We have a dedicated in-house regulatory team which assists in a broad range of Regulatory Consultations for most effective approvals and strategies. We cater from local to global submissions. Having a better understanding of the Indian regulatory scenario, we provide the best assistance to resolve any queries raised by the "Drug Controller General of India" (DCGI) and follow-up submissions for faster approvals.
What we do for you:
IRB/IEC Submissions:
PHARMACOVIGILANCE
NexusCRO offers pharmacovigilance solutions for clinical safety, post-market surveillance and risk management or risk minimization plans. Our Medical Affairs team is comprised of experienced clinical professionals who analyze the safety profile of their products throughout all the phases of clinical development and post-marketing.
Our pharmacovigilance management plan describes in detail the safety processes unique to each client. We also provide full database and hosting services that encompass the collection and management of safety data, from database build to validation to international reporting. Clients have the ability to access their safety data remotely, anytime, anywhere and in real-time.
Our Pharmacovigilance Services include:
- Safety Management Planning.
- Clinical Protocol Safety Section Development.
- Protocol review.
- Case record form review / SAE form development.
- Investigator Brochure review.
- SAE collection, evaluation, classification, and reporting.
- Processing of Serious Adverse Event or Unanticipated Adverse Device Effect reports Coding Review .
- Periodic Safety Update Reports (PSURs), Annual Reports or End of Study Reports
- Medical case review.
- Safety database development and maintenance.
- Adverse event narratives and coding.
- Regulatory reporting.
- Setting Up of Global Phamcovigilance Systems as per regulatory requirements .
- Reconciliation Services - Safety/Clinical Databases.
- Regulatory Dictionary Coding - MedDRA, Sponsor Specific.
- Remote access through a secure line.
MEDICAL WRITING & TRANSLATIONS
Medical Writers have medical, pharmaceutical and life science backgrounds and are experienced in producing high quality Phase I–IV clinical documentation across a wide range of therapeutic areas that strictly adhere to ICH-GCP guidelines and local regulatory requirements. We understand the importance of communicating the details clearly, concisely, and accurately. Our document preparation process involves experts from Biometrics, Regulatory and Medical Affairs who are readily accessible for review and feedback and proactively provide solutions. The input of our team ensures that our client's key messages are medically and scientifically sound and acceptable to the clinician and researcher alike. Our documents undergo rigorous quality assurance review before delivery to our clients.
Medical Writing Projects include:
- Clinical development plans
- New drug Applications
- Clinical Study Reports
- IMP Dossiers
- Clinical study protocols and amendments prepared to ICH-GCP
- Subject information sheets and consent forms
- Investigator's Brochures
- Benefit/risk assessment reports
- Pre-FDA meeting briefing documents
- Informed Consent Documents
- Annual Clinical study Reports
- Periodic Safety Update Reports (PSURs) and other pharmacovigilance documents.
- Integrated Summaries of Safety and Efficacy (ISS/ISEs)
- Package inserts, patient information leaflets
- Summary of product characteristics
- Submissions to ECs/IRBs and health authorities
- Correspondence
- Protocol synopses
- Protocol
- Subject information sheets
- Medical reports
- Abstracts
- Patient instructions
- All other study related documentation
Our Translation team consists of native speakers with many years experience in translating all documents necessary for the performance of clinical studies, such as:
QUALITY ASSURANCE/AUDITING
Quality Assurance includes all planned and systematic evaluations necessary to ensure that all quality requirements are fulfilled and that a trial is conducted, the data generated, documented (recorded) and reported in compliance with GCP and regulatory requirements.
At NexusCRO we are committed to building quality into all our processes through implementing and maintaining a documented Quality System encompassing quality control and quality assurance. This Quality System includes effective Standard Operating Procedures (SOPs) and appropriate training of staff to fulfil their role within the organisation. (Clintech) Compliance with the Quality System is verified through independent Quality Assurance and individually tailored audit programmes ensure the submission of high quality data that meets local and global regulatory requirements.
Our Quality Assurance (QA) team has the clinical and technical expertise to ensure that the appropriate quality systems are in place for our client's clinical study, the rights and safety of the subjects have been adequately protected, the validity and integrity of the clinical study.
Our Quality Management Group can assist you in managing your quality management systems, by: (Harrison) :
- Reviewing current structure and policies, processes and documentation
- Establishing a comprehensive and efficient system enabling a consistent quality structure
- Identifying and initiating corrective and preventative actions to continually improve your processes
- Assistance in writing, reviewing, updating and adapting standard operating procedures (SOPs) to your specific needs and minimum requirements
- Training auditors and quality managers
- Preparation of training plans and documentation for training In addition to providing routine internal quality assurance support, our QA team provides auditing services to its clients.
- Pre-Regulatory Inspection GCP Audits/Inspection Readiness
- Clinical Investigator Site Audits
- Database Audit
- Clinical study report Audit
- System/Process Audit
- Protocol, protocol amendment, consent forms, patient/volunteer information leaflet and CRF’s
- GMP/Investigational Product Storage, Distribution & Manufacturing
- GLP/Central or Local Laboratories
- Clinical and Specialty Vendor & Service Provider Audits/Assessments
- IRB Audits
- Trial Master File Audits
- Validation/21 CFR Part 11 Compliance Audits
- Standard Operating Procedure (SOP) Evaluations
NexusCRO offers an audit service for investigator sites as per protocol-specific standard operating procedures, ICH-GCP and other regulatory requirements. In addition, auditing of archives, drug storage and distribution facilities, clinical laboratories, as well as vendors/suppliers to the clinical trial processes are available.
Auditing Services include:
Auditing services in short provide a snapshot of the trial.
BIOANALYTICAL
All assays and methods are validated according to US-FDA guidelines. In addition to providing support for in-house clinical pharmacology activities, our bioanalytical unit also routinely provides support for clinical studies conducted at other sites.
Our Services:
- Quantitative analysis of parent drugs and their metabolites in a variety of biological matrices
- Develop/validate new assays
- Implement/validate client’s own assay
- Analysis of enantiomeric drugs components
- Support external pharmacokinetic studies