Site management services, Study Staff Training, Site SOP preparation, Feasibility, IRB/IEC Related.

Samahitha - Services

You Name It, We Do It!

We, with Our dedicated team of Clinical Operations experts provide site management services for phase trials, BA/BE, observational studies and what not!

If you are looking for site management services with the most proactive approach then you are at the right place!

Yes, we at Samahitha, have an extraordinary team of experienced Clinical Research coordinators and assure to provide you the best site services you can ever experience.

Our site management services include

Study Staff Training

We appoint experienced CRCs and study managers at the site for easy and smooth conduction of trials. GCP and study specific Trainings will be provided to all the study staff by our experts.

Site SOP preparation

Site Specific Standard Operating Procedure for Clinical Trials is a must for the conduction of trials. We prepare site specific, GCP Compliant SOPs for smooth conduction of any trial.

Identifying the potential sites and investigators, assist in feasibility assessment and site initiation. Feasibility Assessment directly bring a vital part of the trial, we make sure to provide you with the best and the most feasible sites.

IRB/IEC Related

Assist for faster submission and approval by the Institutional Review board or ethics committee.

Contract and budget assistance

Efficient Site contract management, cost analysis and budget negotiation for each of the trial that comes to us.

Subject recruitment

Being the pivotal objective of any trial, the success of any trial depends on the number of subjects recruited after screening the eligibility criteria. Our experienced CRCs and study team will assist you for faster and gratr recruitment rate.

Informed Consent Process

Each subject who is enrolled in the study have the right to know every detail about the clinical trial of which he/she would be a part. The entire process of Informed consent would be assisted by our experienced study staff.

Patient care

Safety of the patient is the primary concern. Our study staff ensure that proper care is given to the subject. Subject comfort is the priority.

Drug Dispensing and accountability

IP storage, handling, dispensing, and documentation of administration, return and/or destruction of the drug.

Subject retention

We make sure that all the subjects randomized complete the study with effective follow up and proper ancillary care.

Adverse events

Effective Detection, recording and reporting of Adverse Events.

Case report forms

Accurate CRF filling, handling and maintenance is assured. Our CRCs are trained and experienced to work on both paper based and EDC based Data Management platforms.

Maintenance of Site Master File

Proper completion and assembly of all the study documents are ensured. We make it easier for you to maintain the site file.

Monitoring and Auditing

We conduct internal monitoring in frequent intervals to ensure proper conduction of the trials. With our continuous monitoring, we ensure smooth conduction of the study with minimal or no protocol deviations.

IP Management

We ensure the proper storage and handling of the Investigational Products. Maintenance of IP temperature logs, IP shipment and related logs are all accurately maintained. IP retrieval and destruction are all taken care.

Study close out

We ensure faster recruitment and proper completion of all subject files. Make sure that the site is all ready for close out before intimating the sponsor/CRO. Continuous assistance and monitoring will be done to ensure smooth completion of trials.

We are happy to note that the services offered by Samhitha Research organisation is prompt and timely. Their approach is professional , customer friendly . The service is exemplary ,quick and prompt. Staff are easily reachable and ready to help any time of the hour. Wish them all the best in thier future endeavours.

Dr.Sanjeev B Rai

Chief of Research, Father Muller Medical College and Hospital, Mangalore

We have been in business with samahitha since 2 yrs. I personally wanted to share a quick note that I am glad about our association with samahitha. They have their Network across India with a good knowledge staff. We would like to have our association with you in future also.

Dr.Chandrashekar K

Project Manager, Croissance Clinical Research