Vimta is a proven and committed partner to Pharma and Medical device industry to bring innovative new products to the market. Vimta is a full-service partner, providing expert services in all key areas of the drug development process:

Services offered by VIMTA
1. Clinical Trial Management (CTM) Services

We provide the full range of services to manage clinical studies from clinical study design to study management to pre-approval and post-marketing services, with an emphasis on providing highest quality standards with our highly motivated and trained team. We implement innovative clinical trial management strategies to meet our sponsor's service level agreements in terms of clinical trial timelines and quality. We have capabilities to manage clinical trials (of drugs and medical devices in patients and) approved by DCGI {Drugs Controller General (India), Government of India} and Independent Ethics Committees/ Institutional Review Boards:

• Site Management & Monitoring including Investigator/ Site Selection & Feasibility, Site Management services such as Investigator training, Site coordination, Ethics committee liaison & development, Study Drug and Document's Management, Site audit preparation & Site Monitoring Services such as planning and conduct of Site initiation, Monitoring, close-out, management of site queries etc.

• Clinical Data Management & Biostatistics;
• Medical monitoring;
• Site Audits
• Consulting Services;
• Regulatory Support.

Our clinical expertise spans all manner of products and therapeutic areas. We have a combined specialized expertise of our investigator's and study staff in therapeutic areas in pharmaceuticals such as Cardiovascular Diseases, Neurology and Neuropsychiatry, Gastroenterology, Dermatology, Oncology, Urology and Nephrology, Orthopedics for Drugs, Biologics and Medical devices including combination products. Our prospective and current clients comprise of both national and international sponsors from virtual- and start-up companies to large corporations. We can manage studies ranging from small feasibility studies to multi-center national and international trials with hundreds of patients.

2. Medical Writing Services

Vimta has a trained and experienced medical writing team to create and manage documents related to clinical research, regulatory affairs and medical support to marketing.

Vimta's Medical writing services include the following:

1. Clinical: Clinical Study Documents management including Clinical trial design and Protocol Development, CRF design, printing, distribution, collection and analysis; Investigator's and ethics committee brochures, Informed consent documents, Clinical Study Reports and Manuscripts, Core Safety Informations & Prescribing Information, interim and final Clinical Study Reports (CSRs), Site initiation, feasibility, monitoring, close-out reports, Drug Safety (AE and SAE) reports and narratives;

2. Regulatory: Preparation and Quality check of Common Technical Document (CTD) (clinical as well as nonclinical modules), Clinical Expert Reports, IND applications& Other clinical trial applications, IDE, PMA/ 510(k);

3. Scientific & Publication Writing: Product Monographs and Manuals, Continuing Medical Education (CME) programs, Slide Presentations/Lectures, Organization of Workshops and Conferences, Textbook Chapters, Professional Meeting Abstracts, Posters, and Highlights, Patient Education Materials, Medical and Scientific Journal Manuscripts and Supplements and (Sales Technical / Medical ) Training Materials.

3. Clinical Training Services

Our dedicated training team provides services for Clinical Research teams to Medical affairs and medicomarketing teams to regulatory affairs and Drug safety teams. The training services include:

• Clinical Research: ICH-GCP training, Study-specific training, training of clinical research coordinators and associates, Principal investigator and study team training;

• Medical support to marketing/ Medicomarketing: Indication/ product specific training to pharmaceutical sales force for product launches, cycle meetings & KOL reachout programs, organizing and conducting focussed workshops, CMEs and Doctor Group meetings, Training in Medical detailing;

• Product Safety & Pharmacovigilance: General training, Process specific (e.g., ICSR processing, aggregate safety report preparation) training, SLA/ Service Management training and Project Management training.

The training programmes range from 1-7 days' focussed training programs onsite at various organizations to off-site (at Vimta) 3months-2 years' advanced training programs in Clinical research, Pharmacovigilance, Medical writing (including Biostatistics & Clinical data management).

Comprehensive pre & post marketing drug safety: The safety services support the product safety program for regulatory compliance and product lifecycle management. We provide support with highly trained, qualified & experienced team dedicated to work on sponsor's product safety requirements.

The services currently available include:

• Triage & Case processing of Individual Case Safety Reports (ICSRs)

• Aggregate Safety Reports

• Post-Marketing Surveillance (PMS) Studies

I. ICSR Data Management:

• Triage / Case Creation for further case processing, based on Minimum Safety Information (MSI)

• Case transcription (Data Entry): Initial & follow-up AE and SAE logging, tracking and accurate data entry & narrative writing.

• Quality review (Safety Review) of AE/ SAE cases: Medical coding including MedDRA and WHO-DD coding (except Medical Devices). Validation for accuracy and consistency of data entry against the source document and initiation of follow-up.

• Physician's medical review of the case report for Seriousness, Causality, Labeling and Medical evaluation.

• Regulatory Reporting: Generation of MedWatch 3500A/CIOMS I/ other applicable regulatory forms, prompt notification of potential expedited IND, alert, and Suspected Unexpected Serious Adverse Reactions (SUSARs) Reports.

II. Aggregate Safety Reports

including Periodic Safety Update Reports (PSURs), Summary Bridging Report (SBR) and Periodic Adverse Drug Experience Reports (PADER), Prompt notification of potential expedited IND, alert, and Suspected Unexpected Serious Adverse Reactions (SUSARs) Reports;

III. Post- Marketing Surveillance (PMS) Studies:

Conduct of high- quality, Phase- 4 safety surveillance study with drugs, vaccines and medical devices at Vimta's associated clinical trial centres at multiple hospital sites throughout India.

• Availability of India wide centres and >100 practicing doctors in various therapeutic areas.
• Availability of central Ethics committee
• Availability of India-wide Central Laboratory services for clinical studies
• Well- qualified and experience study management team
• Project Management and Medical writing support

Service Models

• Full-program outsourcing: End-to-end case processing, literature search and aggregate safety reporting services;
• Stand-alone services: Each process in Case Processing such as Triage, Data Entry, Quality Review, Medical Review, Aggregate Safety Reporting.

Advantage Vimta:

We have 2 decades of experience in ensuring quality of all our services and regulatory compliance of FDA, EMEA, BfARM & other regulatory bodies for our clinical research activities.
We ensure that the right information is given and collected so that all protocols, SOPs & regulatory guidelines are followed and timelines are met. We have flexibility, knowledge and experience to work on our Customer's proprietary or licensed electronic databases for clinical data management (including 21 CFR Part 11 compliant EDC solutions) & product safety (case processing & aggregate safety reports such as Argus Safety, Aris-G, Empirica Trace, etc.). We are well trained and experienced in the current clinical research (such as ICH-GCP, FDA, EMEA & Schedule Y etc.) and safety reporting guidelines (such as ICH E2A & E2C, CIOMS, US FDA's Good Pharmacovigilance Practices and EMEA's European Directive 2001/20/EC).
We cater our service offerings with strict adherence to the client specified Service Level Agreements (SLAs) resulting in effective client engagement.