Clinical Research Project Management

We present qualified, pre-screened, Principal Investigators for participation in clinical trials in almost all therapeutic specialties.

We have established relationships with many experienced, qualified and enthusiastic Clinical Investigators and Clinical Research Coordinators. This includes single practitioners, large single and multi-speciality practices, physician networks, hospital based physicians, and academic medical centers. We ensure timely and Accurate Regulatory Board Submission and Data Collection We will provide all sites with dedicated, full time, and experienced clinical research coordinators to ensure the prioritized and accurate submission of regulatory documents, appropriate site orientation/initiation, patient recruitment, screening and enrollment as well as the collection of clean and accurate data.

Regulatory and Medical Writing

In any business, Content is the key of success for positioning of any product. An article plays an important role.

In generating awareness and enables any company to connect with and influence the target audience. We have a team of experts in the field of writing with an eye of detailing and creative mindset. The team focuses on the highest standards of deliverable and crafts effective readable scientific and medical information Medical Writing is an integral part of communicating the result of any kind of medical research.
We believe in quality and delivering accurate, timely, and cost effective documents to the highest ethical and scientific standards. With experts in the team, we are capable of bringing out the best from the research and accurate interpretation of any finding.
We have dedicated team to assist new and experienced authors, researchers who are daunted by publication process and fail to submit their work due to lack of time and quality to a peer-reviewed journal or scientific talks.
We assist our client from inception of a concept to its publication both for research and medico-marketing purpose. We are dedicated to produce best quality, assured and timely publications. s a communication specialist, we provide intellectual input and contribute to making communication accessible to specific audiences. We provide services for: Publication writing

Site Management

We establish a mutually beneficial working relationship with experienced, enthusiastic and ethics-minded physicians.

who share our philosophy. We provide Investigative Sites with different kinds of services to assist in the establishment of a new clinical research component to an existing practice as well as provide services that can strengthen and increase the core capabilities of the Site and personnel.

Training and Development

We are offering an educational program for the investigators and consultancy services to the institutes for designing courses.

In clinical research, Training to the members of ethics committee, Medical Representative training with slide kits to product training manuals, with onsite training both for medically, sales and communication training.
Our services include:
Developing course curriculum and designing short term and long term courses in clinical research
On site developmental training for investigators and staff
On site facility assessment
Customized Programs, Working with/interacting with Institutional Review Boards (IRB), Effective subject consent processes, Ethics/Protection of human subjects, Current industry standards (GCP, GLP, GMP), Regulatory document preparation and maintenance.

Clinical Data Management

Input to protocol design, Operational project planning, Creation of data management plan and data validation plan, pCRF/eCRF design.

Database design and edit check programming, Database testing and UAT, Data migration, Scanning and Indexing, Data entry, External data loading, Data review and query, Management, External data management, SAE reconciliation, Medical dictionary coding, Quality control activities, Helpdesk to support investigators and site staff, Self-help portal for Inform users, Project documentation (Data Master File), Database Freeze/lock, Submission ready PDRs, Data transfer, Archival.

Pharmaco vigilance

Individual case safety reports (ICSR) processing. (receipt, validation, triage, data entry, quality reviews, medical review

Aggregate report writing (periodic safety update report, periodic benefit risk evaluation report, PADER etc.), Adverse event database set up and management considering ICH e2b, Preparation and maintenance of prescribing information including timely revision, Preparation of system documents like detailed description of pharmaco vigilance system, Risk evaluation and mitigation strategy report preparation, Medical information call center management with product quality complaint management, Preparation of regulatory queries pertaining to drug safety, Reparation and management of safety data exchange agreement and routine reconciliation, Clinical trial related documents Preparation including management of safety management plan, Conduct and design post marketing safety studies, Drug safety department process set up, Signal detection and benefit risk assessment report preparation and management.

Patient Management

Individual case safety reports (ICSR) processing (receipt, validation, triage, data entry, quality reviews, medical review).

Developing Course Curriculum

We provide complete solutions, from brand building to medical education. We have team of industry professionals from different expertise.