Our Services

Services

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Strategic Consulting

We provide Excellent Consulting Services to our Customers. Our Resources, products and processes accelerate the application functionality to run your systems efficiently. We offer Competitive rates and flexible engagement models which help Customers increase Business performance and IT operations.

Outsourcing

Our Outsourcing strategy will ensure low cost and high operational efficiency. Our experienced Professionals will understand your business, provide customized solutions and leverage new technologies for beneficial outcome. Customers looking for best practices, innovations and frameworks for delivering sustained business value Prefer KN Tech Solutions.

Systems Integration

We offer system integration and services for custom applications, ERP Applications and 3rd party software’s across the Business modules in an Organization. Whether you acquired a company or merge with another Company KN Tech Solutions is here to help Integrate your systems and achieve better results.

Application Development

KN Tech Solutions has End to End solution for Application Development. Our Application Development suite includes Requirement analysis, picking the right technology considering the budget, highly experienced professionals, cost effective models and on time delivery schedules. With our comprehensive suite we help customers achieve the goal right on time.

ERP Services

We have provided optimized management solutions and ERP services covering implementation, consulting, operation & maintenance to Customers in US. We also provide technical support by leveraging a seamless combination of rich project experience and Sustainable industry solutions.

Adhering to the philosophy of customer focus and excellence by innovation, we are dedicated to provide users with the best ERP platforms and top-notch services.

Clinical Recruitment Services

Access the best talent to meet you strignent requirement on Bio-metrics, including clinical data management and SAS programming, Pharmacovigilance/drug safety, Regulatory affairs, Validation, Quality and compliance.

Select the staffing model that best meets your hiring needs, the scope of your project and the level of strategic assistance you require:

Temporary/contract staffing

Contract-to-permanent staffing

Permanent staffing

Functional service provider (FSP) solutions

Managed service provider (MSP) solutions

Help Desk

Remote support every hour of every day.

Our remote support Help Desk provides an efficient way to provide immediate support to our customers. It’s convenient and fast. We’ve found that the vast majority of our customer’s technical problems can be resolved over the phone or with an online chat. We offer customers the benefit of our Help Desk services in distinct ways:

24/7, 365 days Help Desk: Unlimited 24/7 live Help Desk support is available 365 Days. Our Help Desk is staffed around the clock with certified technical network consultants available to provide immediate assistance.

Outsource Help Desk: We know how to run a busy help desk. And we’re confident that we can run yours. We provide full or part-time outsourced help desk service, application support center or service desk for your employees or customers.

QA

We offer a broad range of testing services KN Tech Solutions offers comprehensive QA consulting services. Based on our expertise in the most effective testing processes and methodologies, as well as the experience with global delivery of QA services to the world’s leading companies, we work with our clients to enable stronger testing processes, more effective and productive QA organizations, and superior application quality.

Pharmacovigilance

KN Tech Solutions has the broad-based experience to provide comprehensive clinical and post-marketed drug safety and pharmacovigilance services to help our clients address product safety concerns in a confident, proactive manner. We provide diligent resources with the abilities to review, evaluation and management of adverse event reports in accordance with applicable health authority regulations and ICH guidelines.

Our professionals will provide services as below:

  • Clinical and Marketed Individual Case Safety Reports.
  • Case Management
  • Aggregate Safety Reports
  • Scientific Literature Surveillance
  • Safety Signal Detection
  • Epidemiology Consultation
  • Risk Management
  • Reconciliation
  • Reporting rules
  • Vendor management
  • Database configurational help
  • Regulatory Consultation
  • Quality and compliance
  • Safety analyses in Regulatory submissions
  • Data Monitoring Committee (DMC) reviews.

Clinical Services

KN Tech Solutions offers services in providing experienced resources who can fulfill the roles of Clinical Trial Managers, Clinical Research Associates, Clinical Data Managers, clinical trial monitors, clinical research scientists, clinical research coordinators. Their essential Functions in projects include:

  • Study Team Leadership
  • Study Planning
  • Selection and evaluation of Investigator Sites
  • Vendor/CRO management
  • Initiation and Site Start-Up
  • Enrollment of Subjects
  • Maintenance of Sites, Subjects, and Data
  • Study Close Out
  • Study Close Out

Biostatistics

KN Tech Solutions provides leading statistical and analytical services in support of clinical trials, regulatory submissions, marketing efforts, and quality initiatives. Our skillful resources apply innovative statistical methodologies to assess efficacy and safety analysis of the drug. Our principal focus is to provide our client with potential service with the abilities in complex areas of study design, concept protocols and data analysis strategy, sample size calculation, analysis methods and interpretations. ScinoRx provides the services understanding the global regulatory requirements and guidelines.

  • SAS software
  • Provides statistical plans for all phases of clinical studies
  • Statistical inputs for development study protocol
  • Reviews clinical study protocols and Case Report Forms (CRFs) for proposed studies
  • Randomization, Power calculation with defined sample size and Interim analysis
  • Designing and development of tables, graphs and listings
  • Recommendation / evaluations on study design and regulatory submissions
  • Interim analysis support for adaptive clinical trials
  • Participate in pre IND and NDA activities
  • Expert personnel to serve as statisticians on Data Monitoring Committees
  • Analysis datasets and integrated database in CDISC format (ADaM) thereby fulfilling electronic submission requirements
  • Assesses protocol deviations to the extent that they affect statistical analyses.
  • Statistical sections clinical technical document integrated summaries of safety and efficacy
  • Statistical support for presentations and publications

Validation

Validation is our niche. KN Tech Solutions offers GxP quality and compliance services to resolve FDA enforcement actions. Our quality and compliance services help the biotech, pharmaceutical and medical device industries with their Quality Management Systems to ensure that their products consistently meet applicable regulatory requirements. We are extensively sophisticated in helping top organizations implement a broad range of software validation and verification based on 21 CFR Part 11.

KN Tech Solutions provides professional services that have the depth of experience in commissioning and qualification to ensure compliance with the applicable regulations and client requirements. We will integrate the ISPE Baseline Guide approach into the project development, complete validation life cycle, commissioning and qualification phases to stream line the qualification process. We provide consultants and services in following areas:

  • Computer System Validation
  • Equipment Validation
  • Cleaning Validation
  • Process Validation
  • Packaging Validation
  • Thermal validation
  • Sterilization Validation
  • Aseptic area and clean room Qualification
  • Analytical Equipment Validation
  • Test method Validation
  • Equipment Qualifications
  • Facilities Commissioning and Qualification
  • Equipment Commissioning and Qualification
  • IT Infrastructure Qualification
  • Design Validation & Verification
  • Medical and technical writing

Scientific Assistance

ScinoRx provides resources to handle a quality role as scientists, Analytical, R&D scientists in formulation. We also provide health care consultants with IT background that can help both in the scientific and technical aspects of the project.

  • Develop and enhance laboratory controls
  • Perform laboratory investigations
  • Assess bioequivalence studies and evaluate adequacy of bioanalytical methods and laboratories
  • Optimize product formulation and processes
  • Assess product stability
  • Evaluate process designs
  • Develop or refine process control strategies
  • Assess and improve process analytical technology (PAT)
  • Evaluate the development of analytical methods
  • Set specifications
Data integrity:
  • Evaluating and enhancing systems to assure data integrity—covering collection, documentation, management, source data changes, and security
  • Assessing data integrity, whether voluntary or required by the FDA.