Infoclin LLP

Phone: 91(0)3348035249

E-mail: subhajitp@infoclinconsultancy.com

Web:http://infoclinconsultancy.in/

Infoclin LLP (A research management company) Introduction Infoclin LLP is a clinical research management company, based at Kolkata, India & business development center in Mumbai, India. Initially it was set up as site Network Company in the name of Infoclin Consultancy in 2014, effective from 2015.Eventually we grasp the network & converted into site network, which is now Infoclin LLP. Since our beginning, we have tried to analyse the setbacks of growth of the trial specifically in the eastern part of India, which is now in Pan India basis & recently started in neighbouring country Bangladesh also.

Vision & Mission • Our purpose is to create healthier lives for people today and generations to come. • We connect our competences in Life Sciences to create solutions that protect and improve human life.  The company was formed with a particular aim, to provide seamless experience to the sponsor, with highest protocol adherence & patient safety at its highest priority & recruitment & retention of the subject at first priority. Today we have created a platform where we are enabled with robust site network in approximately 13 cities of the country & government medical college/academic institutions in majority no. 

Key contact person: 

1.Subhajit Patra Contact No-9748457201 subhajitp@infoclinconsultancy.com Partner, B.Pharm & Pursuing EMBA from SP Jain school of global management Responsibility- Business development, Start-up activity & finance Total Experience-13 yrs. 

2.Swapan Biswas Contact No.-8670254077 swapan@ infoclinconsultancy.com Partner, M.Pharm(Clinical Pharmacology) Responsibility-Regulatory affairs, Quality control, Patient recruitment & retention strategy Total Experience-13yrs. 

3.Sabyasachi Banerjee Contact no-8450822542 sabyasachi@infoclinconsultancy.com Partner, Dual masters in Zoology & International relationships Responsibility-Clinical operation Total Experience-9yrs. 

Services we are offering:

 We provide comprehensive clinical trial, compliance & regulatory services to sites, sponsors, ethics committees & research organizations in India. 

We provide services which include: 

  • Cost effective & efficient Project management 
  • Real world evidence study
  • Pharmacovigilance
  • Scientific and regulatory writing, 
  • Clinical study monitoring, 
  • Medical affairs, 
  • Regulatory affairs, 
  • IP(Investigational Product) Management, 
  • Clinical trial documentation, 
  • Quality system implementation & audits, 
  • Site management, 
  • Investigator and site selection (feasibility studies), 
  • Training and skill development in research and healthcare Ø Ethics committee constitution & registration, 
  • IT related services to pharmaceutical industries, clinical trial sites, and ethics committees,
  • Statistical analysis,
  • Clinical study report preparation,
  • Logistics management,
  • General consulting, 
  • NABL & CAP accredited lab service,
  • Archival facility to store study documents as per the guidelines. 

 

Our team is fully competent and confident in handling global to local, pilot to pivotal studies giving utmost prominence to research ethics, quality, cost and clock. 

 

Why Infoclin 

1. • In site network level 44+ projects is on-going & approximately 50+ project in pipeline 

2. Human resource • Recruitment of Human resource who are really passionate about the industry with relevant knowledge on pharmaceutical sciences, human biology related subjects. After recruitment detailed on-site & off-site training inhouse & by external renowned industry professionals. Result is that today Infoclin is with a workforce of 84 & counting; skilled, regular professionals with diversity knowledge background from PharmD, B.Pharm, Masters in human biology, bio-technology, microbiology & MBA, which is also enriching our workforces to learn in a cross-knowledge environment. • Software based Geo fencing enabled attendance system for office & site personnel also, which is ensuring time-bound & time-efficient activity(40 hrs in a week & holiday on every Saturday & Sunday) • Health scheme & provident fund facility for all the employees • Mandatory training for ALCOA Principle for all the employees. • Mandatory training & certification for IATA for handling medicine. 

3.Site network • Robust site network in approximately 12 cities & increasing in mostly government medical college, 40+Institution & 1400+ active dr. databases. • As site network till date accomplished 170 study (Probably highest in the country) in indication like cardiology, oncology (including hemato & medical onco), Endocrinology, Ophthalmology, Dermatology, Rheumatology etc. • Recruitment experiences of more than 4000+ subjects. • As per our SOP, we provide trial related facility (Deep freezer, refrigerator, desktop, printer, cupboard, thermos-hygrometer) to all the institute • Nutshell of our performance in 2022 No. of Feasibility Done: 93 No. of EC Submission Done: 62 No. of EC Approval Received: 47 No. of CTA Executed: 34 No. of Studies Initiated: 30 No. of NCE (New chemical entity) Trial: 3 No. of Patient Recruitment (total number for all initiated studies): 512 No. of Studies in “Top 3 Recruitment List in India”: 11 Internal QC audit: 55 No of training: 36 

4. SOP Implementation • Creating an effective SOP with regular improvisation fuelled by robust analysis based on available market data & our observation & as per standard guideline like ICH GCP guideline & NDCT Rule, 2019(Annexure attached). 

5. Recruitment strategy • We took initiatives to create a departmental cross-function to increase patient recruitment (e.g.-For Non-squamous cell lung carcinoma we collaborated with the department of radiotherapy with department of medical oncology & pathology & radio-diagnosis department). • We took a detailed, elaborated strategy to reduce patient loss-to follow up. Strategies was included recruit geographically advantaged patient, council them regularly, take care of their health status on a regular interval (not included in protocol specified policy), communication with the hospital administrators & make sure their visit at the hospital hassle free, in adverse event condition communicate them properly & liaison with the investigators about do’s & don’ts & if necessary arrangement for hospitalization. • We have good liaison with the NGO’s, by their support we conduct camp in rural areas in combination with the institutional dr’s to identify potential patients for the study. 

6. Client database • Working with 19 global & domestic sponsor companies & 14 globally renowned CRO company, which has given us detailed insight in terms of clinical operation, data management, and patient safety maintenance & protocol adherence procedure. • We created a communication mechanism to update the sponsor (Pharmaceutical Company) of any event in the trial & regular updating of the trial status. • We tried to do the feasibility of the shared protocol from the pharmaceutical company, very intrinsically & vigilantly about the trial site, available resources & available institutional policy. 

7. Awareness programme • We took initiatives to increase awareness of clinical trials of the stakeholders (Dr, research professional, ethics committee members) through GCP (Good clinical practice, globally approved framework to execute a clinical trial) training session, multiple workshop single or multiple institute model & obviously online & offline platform. In 2022 only we will have conducted approximately 15 GCP (Approximately 500+ dr’s attendance) workshops standalone. • Till date we have registered 13 Institutional Ethics committee 

8. Internal review • Review the quality of work of the team through the departmental QC & QA team & based on requirement QC analysis by external experts also. 

9. Vendor relation • We created a communication channel with the logistics partner for availability of trial supplies at the site effectively & efficiently. • Collaboration with necessary vendors for lab service, logistics, electronic data capture & courier service (bio specimen & Investigational product) 

10. Government approval • We have all the necessary Government of India approval to run the company including registration in Ministry of Corporate Affairs, Micro, small, medium enterprise (MSME) certificate, GST & necessary approval in state level City we are working Kolkata, Siligury, Guwahati, Bhubaneswar, Cuttack, Delhi, Visakhapatnam, Mumbai, Bangalore, Mysore, Jaipur, Lucknow Recently we have started in Bangladesh also. Studies till date we have performed: Till date we have initiated (SIV) 170 study including domestic & global sponsor/CRO.

For detailed contact information visit location pages below.

Infoclin LLP's locations around the world

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